FDA-Cleared HBOT Chambers: Full List and Classes

Medical Disclaimer: This article is for informational purposes only and does not constitute medical advice. Consult a qualified healthcare provider before pursuing HBOT.

At-a-Glance: Cleared Chambers by Class and Manufacturer

How FDA Clears HBOT Chambers

The FDA regulates hyperbaric chambers as medical devices under product code CBF. All chambers fall under 21 CFR 868.5470 — Hyperbaric Chambers.

The agency uses two classifications. Class A chambers operate above 1.4 ATA on 100% oxygen and require 510(k) premarket notification. Class B chambers stay below 1.4 ATA and are wellness devices not intended to treat disease. See complete FDA-cleared chambers list for the complete chamber-by-chamber list.

Every cleared chamber appears in the FDA 510(k) database with a unique K number. The K number traces the device back to its predicate, the legally marketed device it claims substantial equivalence to.

What 510(k) clearance actually means

510(k) clearance is not approval. It means the FDA agrees the device is substantially equivalent to an existing cleared device per FDA Guidance on 510(k) Substantial Equivalence 2014.

The manufacturer files a premarket notification, lists the predicate, and submits technical specifications. The FDA reviews for safety and substantial equivalence within 90 days.

Clearance is not a clinical efficacy endorsement. It addresses device safety, not whether HBOT treats a specific condition.

Class A vs Class B: The Critical Distinction

Class A chambers reach the pressures required for the 14 UHMS-cleared indications. Standard clinical pressure is 2.0–2.4 ATA, with deep tables reaching 2.8–3.0 ATA for decompression sickness and gas embolism. See the arterial gas embolism evidence atlas for the full study-by-study evidence breakdown.

Class B chambers — the soft-shell consumer models — top out at 1.3 ATA. The pressure dose differs from a clinical chamber by roughly 4-fold in terms of dissolved plasma oxygen Mathieu et al., Diving Hyperb Med 2017.

The FDA consumer guidance 2021 is explicit that soft-shell chambers under 1.4 ATA are not cleared to treat any of the UHMS-listed conditions. Marketing them for those uses violates labeling.

Sechrist Industries Monoplace Models

Sechrist is the volume leader in US clinical monoplace chambers. The Sechrist 3600H 510(k) K013313 cleared in 2002 anchors the company's current product line.

The 3600H reaches 3.0 ATA with full UHMS protocol support. The acrylic shell allows patient visibility. The chamber uses 100% oxygen as the breathing gas.

Sechrist also makes the 3300H and 4100H models. Both follow the same predicate lineage through earlier Sechrist clearances.

Perry Baromedical Multiplace Models

Perry Baromedical specializes in multiplace chambers — large rooms that hold 2 to 14 patients plus medical attendants. The Sigma 34 510(k) K023281 is the company's flagship.

Multiplace chambers pressurize with compressed air. Patients breathe pure oxygen through masks or hoods. The advantage is the medical team can enter and intervene during treatment.

Hospitals use multiplace for critical care patients, ventilator-dependent patients, and mass casualty events. The Sigma 34 supports 14 patients at 3.0 ATA.

ETC Biomedical and Fink Engineering

ETC Biomedical's BARA-MED 510(k) K950566 is a hospital-grade monoplace cleared in 1995. The company supplies many military and VA hyperbaric programs.

Fink Engineering's Monoplace 2200 510(k) K081632 is an Australian-engineered chamber cleared in the US in 2008. The model targets clinic and hospital outpatient use.

Both manufacturers compete with Sechrist for the clinical monoplace market. Pricing for new monoplace chambers from these vendors runs $80,000–$150,000 per the CMS 2024 OPPS payment file reference values.

OxyHealth, Summit to Sea, and Newtowne: Class A Soft-Shells

OxyHealth dominates the consumer soft-shell market. The Vitaeris 320 510(k) K020258 cleared in 2002 set the template.

Despite the soft-shell construction, the Vitaeris is technically Class A by FDA pressure classification — though at 1.3 ATA, the therapeutic dose is far below clinical chambers. The chamber uses ambient air or an oxygen concentrator output.

Summit to Sea and Newtowne Hyperbarics offer similar consumer chambers with their own 510(k) clearances. All three operate at 1.3 ATA and serve the wellness and home-use market.

Hospital-grade vs home soft-shell

The 1.3 ATA pressure limit places these chambers outside published clinical efficacy data for the 14 UHMS indications. The FDA consumer guidance 2021 explicitly cautions consumers about marketing claims for soft-shell chambers.

That said, soft-shells are legitimate wellness devices when marketed appropriately. They are not substitutes for clinical HBOT for serious medical conditions.

How to Verify a Chamber's FDA Clearance

The FDA 510(k) database is searchable by manufacturer, product code, K number, or device name. Searching product code CBF returns every cleared HBOT chamber.

For each clearance, the database lists the K number, predicate device, submission date, and decision date. The manufacturer's 510(k) summary or statement is typically downloadable.

If a chamber's manufacturer cannot provide a K number, the chamber is not FDA-cleared. Avoid purchase.

Adjacent Regulations That Matter

ASME PVHO-1 (Pressure Vessels for Human Occupancy) governs the mechanical construction of hyperbaric chambers per ASME PVHO-1-2019. All cleared US hyperbaric chambers comply.

The NFPA 99 Health Care Facilities Code 2024 Chapter 14 governs hyperbaric facility design, fire safety, and emergency protocols. Hospital programs follow this standard.

The CMS 2024 OPPS payment file sets Medicare reimbursement under HCPCS code G0277. The CMS National Coverage Determination 20.29 (2023) defines covered indications.

Choosing the Right Chamber Type

For hospital programs treating the 14 UHMS indications, Class A hospital-grade chambers (Sechrist, Perry, ETC, Fink) are the only credible option. The 2.0–3.0 ATA pressure dose is required to meet published protocols.

For freestanding wound care clinics, Class A monoplace chambers are standard. The CMS reimbursement model under NCD 20.29 supports this configuration.

For home and wellness use, Class A soft-shells (OxyHealth, Summit to Sea, Newtowne) are the legal options. Set expectations appropriately given the pressure limit.

Frequently Asked Questions

Are soft-shell chambers FDA-approved? No chamber is FDA-approved — HBOT chambers are FDA-cleared via the 510(k) process per the FDA 510(k) database. Approval is reserved for higher-risk Class III devices.

Can I use a soft-shell chamber to treat a wound? The FDA consumer guidance 2021 cautions against using soft-shell chambers for the UHMS-listed conditions. Clinical wound protocols require 2.0–2.4 ATA.

Does FDA clearance mean the chamber works? No. 510(k) clearance addresses device safety and substantial equivalence to a predicate, not clinical efficacy for any specific condition.

What's the difference between monoplace and multiplace? Monoplace holds one patient breathing 100% oxygen. Multiplace holds multiple patients plus staff, with patients breathing oxygen through masks while the chamber pressurizes with air per the UHMS 2023 guidelines.

How do I find a cleared chamber's K number? Search the FDA 510(k) database by manufacturer name or product code CBF. The 510(k) summary or statement is typically downloadable.

Related Reading

• Top 10 HBOT Chamber Types Compared 2026
• Mild HBOT vs Hospital-Grade HBOT 2026
• Soft-Shell HBOT Chambers Under 10K Compared 2026

— The HBOT Finder Team