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FDA stops accepting PVHO-1-2019 declarations of conformity on 26 December 2026

Recognition 1-154 for PVHO-1-2019 is superseded by 1-181 for PVHO-1-2023, with a declaration-of-conformity cutoff of 26 December 2026.

Last updated 31 August 2026

Recognition 1-154 for PVHO-1-2019 is superseded by 1-181 for PVHO-1-2023, with a declaration-of-conformity cutoff of 26 December 2026.

The dated statement

The FDA Recognized Consensus Standards entry for ASME PVHO-1-2019, recognition number 1-154, carries a transition period notice. Verbatim: “FDA recognition of ASME PVHO-1-2019 [Rec# 1-154] will be superseded by recognition of ASME PVHO-1-2023 [Rec# 1-181]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 1-154] until December 26, 2026. After this transition period, declarations of conformity to [Rec# 1-154] will not be accepted.” The same entry records FR Recognition List Number 059 and a date of entry of 12/19/2022.

Recognised editions for product code CBF, chamber, hyperbaric, as listed on 31 August 2026
StandardRecognition numberStatus
ASME PVHO-1-20191-154Declarations of conformity accepted until 26 December 2026
ASME PVHO-1-20231-181Supersedes 1-154
NFPA 99:20211-153Listed
NFPA 99:20241-180Listed

What this is not

This is a rule about paperwork in premarket submissions. It is not a recall, not a safety notice, and not a statement that a chamber built to the 2019 edition becomes non-compliant on 27 December 2026. We did not find, and are not asserting, any FDA statement about chambers already in service. Nothing on the classification page for product code CBF says which edition any particular chamber was declared against, and neither do we.

Why a spec table cares

Several manufacturers state ASME PVHO-1 conformity on their product pages without naming an edition, which our comparison notes already flag. An undated “meets PVHO-1” claim now spans two editions, one of which is on a declaration cutoff. That is a question to put to the manufacturer, not a figure we can transcribe.

What it means if you are buying

If you are buying a new-build chamber that will be submitted or supplied after December 2026, ask which edition of PVHO-1 the declaration of conformity names.

How this was verified

Both FDA pages were fetched with caching disabled on 31 August 2026 and the transition wording above was copied from the 1-154 detail sheet. The product classification page for code CBF was read the same day and listed all four recognitions in the table above.

Sources