If you are choosing an HBOT clinic, evaluating a home chamber, or trying to make sense of marketing claims, FDA clearance status is the single most concrete piece of information you can verify. This page documents every hyperbaric chamber model that has received FDA 510(k) clearance under product code CBF — pulled directly from the openFDA 510(k) database as of mid-2026.
There are 69 chambers on the list. Many people who shop for HBOT services are not aware that the universe is this small.
Why FDA clearance matters
Hyperbaric oxygen chambers in the United States are Class II medical devices regulated by the FDA's Center for Devices and Radiological Health. To be legally marketed for medical use, a chamber must demonstrate that it is "substantially equivalent" to a predicate device already on the market — this is the 510(k) premarket notification process. Clearance is not the same as approval (the higher PMA pathway), but it is a meaningful safety floor.
Why this distinction matters for patients:
- An FDA-cleared chamber has been reviewed for safety and substantial equivalence. Pressure controls, fire-suppression standards, emergency-release systems — all checked against a predicate device.
- A non-cleared chamber has not. Some "wellness center" soft-shell chambers sold for home use have never been through 510(k) at all. They are sold for "general wellness" rather than as medical devices, which is a legal status that exempts them from the device pathway entirely — but also means no FDA reviewer ever looked at the safety case.
- "FDA registered" is not the same thing as "FDA cleared." Any company can register with the FDA. Registration costs $5,672/year (2025 fee schedule). It does not imply review, clearance, or approval. Marketing language that conflates the two is intentionally misleading.
The FDA issued a public warning in 2018 about the safe use of HBOT devices, with specific attention to fire risks. The warning underscored that off-label use of HBOT does not eliminate the underlying device-safety standards — chambers used for off-label indications still need to be FDA-cleared to be operated as medical devices.
The 69 cleared chambers, by manufacturer
The full list, grouped by 510(k) applicant and sorted by clearance count.
Sechrist Industries, Inc. (5 clearances)
The dominant US manufacturer of monoplace medical chambers. Founded 1966, based in Anaheim, CA. The Sechrist 3300/3300H is one of the most common chambers in hospital wound-care and hyperbaric-medicine departments.
- K140559 (2014) — Sechrist Monoplace Hyperbaric Oxygen Chamber
- K100268 (2010) — Sechrist Monoplace Hyperbaric Oxygen Chamber
- K052713 (2005) — Model 3300E/ER Monoplace Hyperbaric Oxygen Chamber
- K040128 (2004) — Sechrist Models 4100/4100H Monoplace Chambers
- K933395 (1993) — Sechrist Hyperbaric Chamber
Reimers Systems, Inc. (5 clearances)
Multiplace chamber specialist. Reimers' RSI 4200 series is used in hospital systems for treating multiple patients simultaneously.
- K102831 (2011) — RSI 4200
- K001985 (2000) — Reimers Systems Multiplace Hyperbaric Chamber
- K993192 (2000) — RSI Hyperbaric Chamber System
- K944086 (1995) — RSI 4200 Hyperbaric Chamber
- K884252 (1989) — Reimers Multiplace Chamber
Perry Baromedical Corp. + Perry Baromedical Services (3 + 3)
The other major US monoplace manufacturer alongside Sechrist. The Sigma 34/40 series is the Perry counterpart to Sechrist's 3300 line.
- K072427 (2008) — Sigma Series Hyperbaric Chamber
- K022538 (2003) — Perry Sigma Monoplace Chamber
- K963207 (1996) — Perry Monoplace Chamber
- K121850 (2013) — Perry Baromedical Sigma 40
- K082114 (2008) — Perry Baromedical Multiplace
- K042113 (2004) — Perry Sigma Series
Pan-America Hyperbarics, Inc. (3 clearances)
Multiplace systems primarily for hospital settings.
Environmental Tectonics Corp. (3 clearances)
ETC produces medical chambers as well as research and military pressure systems.
Oxyheal Medical Systems, Inc. / Oxyheal Health Group (2+ clearances)
Multiplace chamber manufacturer. The OxyHeal 4000 received clearance in 2017.
- K163109 (2017) — OxyHeal 4000 Multiplace Hyperbaric Chamber Family
- K152223 (2016) — Rectangular Multiplace Hyperbaric Chamber System
- K052866 (2005) — OxyHeal 1000 Monoplace Hyperbaric Chamber
Gulf Coast Hyperbarics, Inc. (3 clearances)
Rectangular multiplace chambers.
- K082455 (2009) — Rectangular Multiplace Hyperbaric Chamber
Other notable clearances
- Fink Engineering Pty, Ltd. — K240569 (2024) — Most recent clearance. FESL/FEDL/FETL Chamber series (Australia-based, exports to US).
- Oxavita Srl — K171899 (2019) — Revitalair 430F (Italian manufacturer)
- US Hyperbaric Network — K220290 (2023) — Revitalair 430+ (rebadged Oxavita)
- Summit to Sea — K072757 (2008) — Dive and Shallow and Grand Dive (the soft-shell chamber line most commonly sold for home use as "FDA-cleared")
- Hyperbaric America, LLC — K081506 (2008) — Presidential Monoplace
- Khrunichev State Research & Production Space Center — K060739 (2006) — A Russian aerospace company's medical chamber.
The full list of 69 clearances is searchable via the openFDA 510(k) database — you can query by manufacturer name, K-number, or date.
The clearance timeline — what it tells us
Decade distribution of HBOT chamber 510(k) clearances:
- 1970s: 1
- 1980s: 9
- 1990s: 20
- 2000s: 29
- 2010s: 8
- 2020s: 2 (as of mid-2026)
The volume of new clearances has dropped sharply since the 2010s. This is not because the industry is dying — it's because the dominant manufacturers (Sechrist, Perry, Reimers) have stable predicate-device lines that don't require re-clearance for incremental updates. Most "new" chambers on the market today are revisions of existing predicates.
What this means for buyers: the chamber you encounter at most US clinics in 2026 is almost certainly built on a 1990s or 2000s 510(k) predicate. That is normal and not a quality concern. The clearance from 2008 is just as valid in 2026 as a clearance from last year.
Hard-shell vs soft-shell — where FDA clearance gets tricky
The cleanest signal in this database is that monoplace and multiplace hard-shell chambers from major manufacturers have FDA clearance through standard medical-device pathways. These chambers operate at 2.0-3.0 ATA (atmospheres absolute), are constructed of steel or aluminum, and are designed for medical use.
Soft-shell portable chambers are a different conversation:
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Some soft-shell chambers ARE FDA-cleared as medical devices. The Sechrist Recompression Chamber (different from their monoplace line), some Hyperlite-style models used in dive medicine, and a handful of others have legitimate 510(k) clearance.
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Most "mild HBOT" or "wellness" soft-shell chambers are NOT cleared as medical devices. They are sold for "general wellness" use, which is a legal category that exempts them from the FDA medical-device pathway. They typically operate at 1.3 ATA — a much lower pressure than medical chambers.
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A 1.3 ATA "mild HBOT" chamber sold for wellness is not the same product as a 2.0 ATA medical chamber. The pressures, oxygen concentrations, fire-suppression requirements, and intended uses are all different.
This is the most common confusion in HBOT consumer marketing. A clinic that promotes "FDA-cleared HBOT" using a soft-shell chamber at 1.3 ATA is sometimes citing the wellness-category status (which does not require clearance) or referring to a different chamber in their inventory than the one used in patient sessions.
If a clinic claims "FDA-cleared" — ask: which chamber model? What's the K-number? Look it up at accessdata.fda.gov/cdrh_docs. It takes 90 seconds.
How to verify any clinic's chamber FDA status
- Ask the clinic for the chamber make and model. Reputable clinics will tell you without resistance.
- Search openFDA 510(k) by manufacturer name. Product code is CBF.
- Check whether the specific model is listed. Manufacturer-level clearance does not always mean every product they sell is cleared — they may sell wellness models alongside medical models.
- Verify against UHMS accreditation. UHMS-accredited facilities are operating under additional standards beyond device-level clearance. As of October 2025 there are approximately 140 UHMS-accredited HBOT facilities in the US.
- Look for K-number transparency. Clinics that publish their chamber's K-number alongside the manufacturer name signal a level of regulatory diligence that wellness centers rarely match.
What the FDA clearance does NOT tell you
To be precise about what 510(k) clearance does and does not signal:
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✅ The chamber meets baseline safety standards for pressure containment and fire risk
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✅ The chamber is substantially equivalent to a predicate device that the FDA has previously evaluated
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✅ The chamber can be marketed as a medical device in the US
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❌ Clearance is NOT an FDA endorsement of efficacy for any particular indication
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❌ Clearance is NOT a guarantee that the chamber will perform as advertised for off-label uses
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❌ Clearance does NOT extend to the clinical protocol used in the chamber — that's the practitioner's responsibility
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❌ Clearance does NOT mean the chamber is the best fit for your specific medical situation
In other words, FDA clearance is a necessary but not sufficient signal. A clinic using a Sechrist 3300 cleared in 2014 has cleared the safety floor. Whether the clinic is well-managed, the staff is trained, the protocol is appropriate for your condition, and the price is reasonable — those are separate questions FDA clearance cannot answer.
Sources and further reading
- openFDA 510(k) Database API — Source for all data on this page.
- FDA Product Classification for Chamber, Hyperbaric (CBF) — Official regulatory classification.
- FDA: Hyperbaric Oxygen Therapy — Get the Facts — Consumer-facing safety guidance and warning about off-label marketing claims.
- FDA Letter to Health Care Providers: Follow Instructions for Safe Use of HBOT Devices — Fire-safety guidance for HBOT operators.
- UHMS Accredited Facility Directory — Trade-association accreditation, distinct from FDA clearance.
- Topical Oxygen Chamber for Extremities — FDA Class II Special Controls Guidance — Adjacent device category for context.
Frequently asked questions
What is product code CBF? Product code CBF is the FDA's product code for "Chamber, Hyperbaric" — Class II medical devices. It's the classification used to track 510(k) clearances for chambers intended for hyperbaric oxygen therapy.
Does FDA clearance mean the chamber treats the conditions clinics advertise? No. FDA clearance is a device-safety designation. It does not validate clinical efficacy for any particular indication. The 14 FDA-approved HBOT indications are separate from device clearance — they govern WHICH conditions HBOT is approved to treat, not WHICH chamber can be used.
Why are there so few HBOT chambers cleared in the 2020s? The dominant manufacturers (Sechrist, Perry, Reimers, ETC) maintain stable product lines built on existing 510(k) predicates from earlier decades. Incremental product updates often don't require new clearances if they remain substantially equivalent to the predicate. New clearances mostly come from new entrants or genuinely novel designs.
Can a home HBOT chamber be FDA-cleared? Some soft-shell home chambers (like certain Summit to Sea and Hyperlite models) have FDA 510(k) clearance. Many do not — they are sold for "general wellness" use, which is a legal category that doesn't require clearance. Always ask for the specific K-number.
Is FDA-cleared the same as FDA-approved? No. 510(k) clearance is a notification-based pathway that allows a device to be marketed as substantially equivalent to a predicate. FDA approval (PMA — Premarket Approval) is a higher-evidence standard reserved for higher-risk devices. HBOT chambers go through clearance, not approval.
Medical disclaimer: This page documents regulatory data and is for informational purposes only. It does not constitute medical advice. The decision to undergo HBOT, and the choice of facility, should be made in consultation with a qualified physician. FDA clearance status is one of many factors in evaluating a clinic — it is necessary but not sufficient.
Last verified against the openFDA 510(k) database on 2026-06-02.
— The HBOT Finder Team