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Ameda, Inc. 17245

by Ameda, Inc.

Ameda, Inc. 17245 is a Class II device made by Ameda, Inc., cleared under FDA 510(k) K973501 on 11 Dec 1997 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00810725020753), active as of 22 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

1 ongoing

This device is named in the recall

Documents

510(k) K973501

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 Number00810725020753 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK973501 Date11 Dec 1997DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K973501 decided 11 Dec 1997 Active
  • FDA GUDID UDI-DI 00810725020753 listed 24 Sep 2016 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0616-2018 FDA Class III initiated 10 Jul 2017

    Two specific lots was incorrectly manufactured containing a UK power adapter.

Timeline

3 dated events

  1. Cleared FDA 510(k) K973501
  2. Listed FDA GUDID 00810725020753
  3. Recall initiated FDA recalls Z-0616-2018

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  • Withdrawn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 milk bag
Model / Ref / Catalog
17245
Primary DI / UDI-DI
00810725020753
510(k) Number
FDA product code
HGX
GMDN term
Breast milk bag
Device class
Class II
Regulation number
884.5160
GUDID distribution status
In Commercial Distribution

Related devices

Category: Breast milk bag

Cleared under the same submission (K973501)

and 8 more cleared under K973501

Similar devices

Also classified as Breast milk bag.

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 10004

    Class II

  • Ameda, Inc. 17115

    Class II

  • Ameda, Inc. 10002

    Class II

See all devices from Ameda, Inc. →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
Other properties (12, all answered No)