Skip to content

Lvb K1

by Huizhou LVB Maternal & Infant Supplies Co., Ltd.

Lvb K1 is a Class II device made by Huizhou LVB Maternal & Infant Supplies Co., Ltd., cleared under FDA 510(k) K241004 on 11 Sep 2024 and listed in FDA GUDID since 19 Sep 2024 (UDI-DI 06935883919016), 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) K241004

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 Number06935883919016 UDI-DI Date19 Sep 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK241004 Date11 Sep 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K241004 decided 11 Sep 2024 Active
  • FDA GUDID UDI-DI 06935883919016 listed 19 Sep 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K241004
  2. Listed FDA GUDID 06935883919016

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Lvb
Generic name
Breast pump, electric
Model / reference
K1
Primary DI / UDI-DI
06935883919016
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 (K241004)

and 8 more cleared under K241004

Similar devices

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

Other devices from Huizhou LVB Maternal & Infant Supplies Co., Ltd.

See all devices from Huizhou LVB Maternal & Infant Supplies Co., Ltd. →

Properties

  • Over-the-counter
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)