Selecting the right hyperbaric chamber means balancing safety, science, and patient comfort, not just aesthetics.
Unregulated imported chambers continue to enter the U.S. market, often marketed as “affordable alternatives.” The problem: they are not medical devices. These units typically operate at low pressures, lack any oxygen control or fire-suppression systems, and fail to meet U.S. standards for ASME, PVHO, or FDA clearance.
Clinics that unknowingly install these chambers risk not only patient injury but also regulatory action and insurance non-compliance. These are not certified pressure vessels, and their use in a medical environment can result in serious safety violations.
All information provided here pertains exclusively to FDA-cleared, ASME-certified, and PVHO-compliant hyperbaric systems.
We do not promote or sell any equipment through this guide, our mission is to educate and protect those entering the hyperbaric field and to uphold the highest standards of safety, transparency, and patient care.
Choosing the right hyperbaric chamber is one of the most important decisions you’ll make when considering Hyperbaric Oxygen Therapy (HBOT). The right chamber ensures treatment is not only effective, but also safe, comfortable, and compliant with national and international medical standards.
While there are many options available on the market, from clear acrylic models to full steel medical-grade systems, understanding what sets each type apart is crucial.
At HBOT Certification and through our affiliated education programs, we only feature FDA 510(k) cleared, ASME, and PVHO-1 certified chambers. These standards guarantee that the chambers are tested under extreme pressures, built with proven materials, and engineered for patient and operator safety.
Acrylic chambers, while visually appealing, are not always the best fit for clinical or athletic environments. Some users enjoy the “open feel,” but others find the visibility uncomfortable or claustrophobic.
These chambers also tend to have higher maintenance requirements and less flexibility in patient positioning, as most do not allow patients to sit upright. For facilities prioritizing function, safety, and daily usability, the design limitations can outweigh the aesthetic benefits.
Acrylic hyperbaric chambers are typically FDA-approved because they meet the minimum engineering and visibility requirements for single-patient treatments, often designed for ease of observation in hospital environments. However, many clinics prefer all-steel chambers due to their superior durability, lower maintenance needs, enhanced privacy, and improved patient comfort during repeated or long-term therapy.
When choosing a hyperbaric chamber, prioritize safety, compliance, and patient experience over aesthetics or price.
Always verify that the chamber you’re considering is FDA 510(k) cleared, ASME certified, and PVHO-1 compliant.
Our educational team provides transparent information on compliant systems only, never untested or imported devices that fail to meet U.S. safety standards.
The FDA 510(k) process verifies that a medical device is substantially equivalent to a legally marketed, safe, and effective product. For hyperbaric chambers, this clearance ensures that the design, pressure capacity, and material composition meet strict medical device standards for human use.
The American Society of Mechanical Engineers (ASME) sets global standards for pressure vessels. Chambers with ASME certification have undergone rigorous testing for structural integrity, ensuring they can safely withstand the high pressures required during treatment.
The Pressure Vessel for Human Occupancy (PVHO-1) standard defines the engineering, fabrication, and testing criteria for any chamber meant for people. PVHO certification means the chamber meets the highest level of safety engineering, protecting both the patient and operator from risk.