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All Flow 5553100

by Alliance Tech Medical Inc

All Flow 5553100 is a pulmonary function testing kit (FDA Class II; FDA product code CAH, Filter, Bacterial, Breathing-Circuit) made by Alliance Tech Medical Inc, cleared under FDA 510(k) K043148 on 13 Dec 2004 and listed in FDA GUDID since 26 Sep 2016 (UDI-DI 00384620000016), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K043148

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00384620000016 UDI-DI Date26 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK043148 Date13 Dec 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K043148 decided 13 Dec 2004 Active
  • FDA GUDID UDI-DI 00384620000016 listed 26 Sep 2016 Listed

Recalls

1 recall · FDA

    • Completed Z-0714-2020 FDA Class II initiated 6 Oct 2014

    Patients have experienced a bad taste associated with the filters.

Timeline

3 dated events

  1. Cleared FDA 510(k) K043148
  2. Recall initiated FDA recalls Z-0714-2020
  3. Listed FDA GUDID 00384620000016

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
All Flow
Generic name
Pulmonary function testing kit
Model / reference
5553100
Primary DI / UDI-DI
00384620000016
510(k) Number
FDA product code
CAH
GMDN term
Pulmonary function testing kit
Device class
Class II
Regulation number
868.5260
GUDID distribution status
In Commercial Distribution

Related devices

Category: Pulmonary function testing kit

Cleared under the same submission (K043148)

and 8 more cleared under K043148

Similar devices

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

Other devices from Alliance Tech Medical, Inc.

See all devices from Alliance Tech Medical, Inc. →

Properties

  • Single use
  • Lot / batch number
Other properties (13, all answered No)