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Oxy-Off(Tm)

by B&B Medical Technologies, Inc.

510(k) K863510

Oxy-Off(Tm) is a medical device (FDA Class I; FDA product code BXY, Flowmeter, Calibration, Gas) made by B&B Medical Technologies, Inc., cleared under FDA 510(k) K863510 on 22 Oct 1986, active as of 11 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 11 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 11 Oct 2026.

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK863510 Date22 Oct 1986ClearedStatusActive

Official records

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  • Withdrawn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
BXY
Device class
Class I
Regulation
21 CFR Part 868.2350
Advisory committee
Anesthesiology
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code BXY (Flowmeter, Calibration, Gas).

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    Class I

See all devices from B & B Medical Technologies, Inc. →