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Ventlab Bacterial Filter, Model BF100

by Ventlab Corp.

510(k) K030271

Ventlab Bacterial Filter, Model BF100 is a medical device (FDA Class II; FDA product code CAH, Filter, Bacterial, Breathing-Circuit) made by Ventlab Corp., cleared under FDA 510(k) K030271 on 7 Jul 2003, active as of 22 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 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK030271 Date7 Jul 2003ClearedStatusActive

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  • Withdrawn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
CAH
Device class
Class II
Regulation
21 CFR Part 868.5260
Advisory committee
Anesthesiology
FDA decision
SESE Substantially Equivalent

Devices cleared under K030271

4 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K030271
UDI-DISize and differences
Aerogen® Solo; Aerogen Ultra 90-212
Aerogen, Inc.
90-21205391517936308 —On the market
Aerogen® Solo; Aerogen Ultra 90-213
Aerogen, Inc.
90-21305391517936322 —On the market
Aerogen® Solo; Aerogen Ultra AG-AS7009-US
Aerogen, Inc.
AG-AS7009-US05391517936339 —On the market
Aerogen® Solo; Aerogen Ultra AG-AS7509-US
Aerogen, Inc.
AG-AS7509-US05391517936315 —On the market

Similar devices

Other devices filed under FDA product code CAH (Filter, Bacterial, Breathing-Circuit).

Other devices from Ventlab Corp.

See all devices from Ventlab Corp. →