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Expresse and Premier Powered Breast Pumps

by Ameda Medizintechnik AG

510(k) K973501

Active United States

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

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK973501 Date11 Dec 1997ClearedStatusActive

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.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HGX
Device Class
Class II
Regulation
21 CFR Part 884.5160
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent