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Ameda HygieniKit Plus

by Ameda, Inc. 2 variants

Ameda HygieniKit Plus (17451) 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 27 Apr 2021 (UDI-DI 00810725022405), 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 Number00810725022405 UDI-DI Date27 Apr 2021ListedStatusListed 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 00810725022405 listed 27 Apr 2021 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 00810725022405

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ameda
Generic name
Breast pump support kit, single-use
Model / Ref / Catalog
HygieniKit Plus, 17451
Primary DI / UDI-DI
00810725022405
510(k) Number
FDA product code
OHH
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

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

  • Supplied sterile
  • Over-the-counter
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)