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Ameda Pearl

by Ameda, Inc.

Ameda Pearl (201W01) is a Class II device made by Ameda, Inc., cleared under FDA 510(k) K221576 on 12 Oct 2022 and listed in FDA GUDID since 19 Jan 2023 (UDI-DI 00810725025864), 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) K221576

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 Number00810725025864 UDI-DI Date19 Jan 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK221576 Date12 Oct 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K221576 decided 12 Oct 2022 Active
  • FDA GUDID UDI-DI 00810725025864 listed 19 Jan 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K221576
  2. Listed FDA GUDID 00810725025864

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  • Withdrawn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, electric
Model / Ref / Catalog
Pearl, 201W01
Primary DI / UDI-DI
00810725025864
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 (K221576)

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
  • Serial number
Other properties (12, all answered No)