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Ameda, Inc. 20001

by Ameda, Inc.

Ameda, Inc. 20001 is a Class II device made by Ameda, Inc., cleared under FDA 510(k) K100435 on 28 May 2010 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00810725022603), 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 found

in data synced 22 Oct 2026

Documents

510(k) K100435

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 Number00810725022603 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK100435 Date28 May 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K100435 decided 28 May 2010 Active
  • FDA GUDID UDI-DI 00810725022603 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K100435
  2. Listed FDA GUDID 00810725022603

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  • Withdrawn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, electric
Model / Ref / Catalog
20001
Primary DI / UDI-DI
00810725022603
510(k) Number
FDA product code
HGX
GMDN term
Breast pump, electric
Device class
Class II
Regulation number
884.5160
GUDID distribution status
In Commercial Distribution

Related devices

Category: Breast pump, electric

Cleared under the same submission (K100435)

and 2 more cleared under K100435

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

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