510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K081506Substantially Equivalent

Hyperbaric America, Llc, Presidential Monoplace Hyperbaric Chamber Systems

Hyperbaric America, LLC, San Antonio TX / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081506 is the FDA 510(k) clearance record for HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS, a class II device, cleared for Hyperbaric America, LLC on under FDA product code CBF (Chamber, Hyperbaric). FDA records list one 510(k) clearance for Hyperbaric America, LLC. As of , FDA records show no recalls naming K081506.

Clearance record

Decision date
Received
(57 days to decision)
Product code
CBF Chamber, Hyperbaric
Regulation
21 CFR 868.5470
Device class
Class II
Review panel
Anesthesiology
Applicant
Hyperbaric America, LLC 1811 Copper Ridge Dr., San Antonio TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CBF

Trailing 12 months

FDA records hold no clearances under product code CBF in the trailing twelve months.

FDA records show no clearances under product code CBF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CBF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260