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Ameda, Inc 10004

by Ameda, Inc.

Ameda, Inc 10004 is a Class II device made by Ameda, Inc., cleared under FDA 510(k) K011519 on 15 Aug 2001 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00810725023082), active as of 22 Oct 2026.

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) K011519

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810725023082 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK011519 Date15 Aug 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K011519 decided 15 Aug 2001 Active
  • FDA GUDID UDI-DI 00810725023082 listed 24 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-1327-2015 FDA Class II initiated 12 Feb 2015 on shared 510(k) K011519

    Devices were not sterilized

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

3 dated events

  1. Cleared FDA 510(k) K011519
  2. Recall initiated FDA recalls Z-1327-2015
  3. Listed FDA GUDID 00810725023082

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ameda, Inc
Generic name
Breast pump support kit, single-use
Model / Ref / Catalog
10004
Primary DI / UDI-DI
00810725023082
510(k) Number
FDA product code
HGX
GMDN term
Breast pump support kit, single-use
Device class
Class II
Regulation number
884.5160
GUDID distribution status
In Commercial Distribution

Related devices

Category: Breast pump support kit, single-use

Cleared under the same submission (K011519)

and 8 more cleared under K011519

Similar devices

Other devices filed under FDA product code HGX (Pump, Breast, Powered).

Other devices from Ameda, Inc.

  • Ameda, Inc. 17148PM

    Class II

  • Ameda, Inc. 17115

    Class II

  • Ameda, Inc. 10002

    Class II

  • Ameda, Inc. 17508RT

    Class II

See all devices from Ameda, Inc. →

Properties

  • Over-the-counter
  • Lot / batch number
Other properties (13, all answered No)