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SPECTRA One Plus

by Uzinmedicare Co., Ltd

SPECTRA One Plus (MM011444) is a Class II device made by Uzinmedicare Co., Ltd, cleared under FDA 510(k) K251423 on 6 Feb 2026 and listed in FDA GUDID since 28 Oct 2026 (UDI-DI 08809108020338), active as of 9 Nov 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 9 Nov 2026

Documents

510(k) K251423

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08809108020338 UDI-DI Date28 Oct 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK251423 Date6 Feb 2026DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K251423 decided 6 Feb 2026 Active
  • FDA GUDID UDI-DI 08809108020338 listed 28 Oct 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K251423
  2. Listed FDA GUDID 08809108020338

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Spectra
Generic name
Breast pump, electric
Model / Ref / Catalog
SPECTRA One Plus, MM011444
Primary DI / UDI-DI
08809108020338
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

Cleared under the same submission (K251423)

Similar devices

Other devices filed under FDA product code HGX (Pump, Breast, Powered).

Other devices from Uzinmedicare Co., Ltd

See all devices from Uzinmedicare Co., Ltd →

Properties

  • Single use
  • Over-the-counter
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)