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ViveCare LVA3075FLG30

by Vive Health LLC

ViveCare LVA3075FLG30 is a Class II device made by Vive Health LLC, cleared under FDA 510(k) K191802 on 16 Jan 2020 and listed in FDA GUDID since 4 Apr 2025 (UDI-DI 00810178882458), 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) K191802

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 Number00810178882458 UDI-DI Date4 Apr 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK191802 Date16 Jan 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K191802 decided 16 Jan 2020 Active
  • FDA GUDID UDI-DI 00810178882458 listed 4 Apr 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K191802
  2. Listed FDA GUDID 00810178882458

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ViveCare
Generic name
Breast pump support kit, single-use
Model / reference
LVA3075FLG30
Primary DI / UDI-DI
00810178882458
510(k) Number
FDA product code
HGX
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 (K191802)

and 8 more cleared under K191802

Similar devices

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

Other devices from Vive Health LLC

See all devices from Vive Health LLC →

Properties

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