Skip to content

Bay Area Hypersciences

by Bay Area Hypersciences, LLC

510(k) K030713

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK030713 Date19 Dec 2003ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CBF
Device Class
Class II
Regulation
21 CFR Part 868.5470
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Bay Area Hypersciences is a hyperbaric chamber device classified under the Anesthesiology medical specialty. It is designed for use in hyperbaric oxygen therapy applications.

The device is manufactured by Bay Area Hypersciences, LLC in Houston, Texas. It received FDA 510(k) clearance with decision code SESE on December 19, 2003, and is classified as device class 2 under product code CBF. The device is supplied in various sizes as indicated by the multiple registration numbers associated with this product.