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THERA Plus 64431942B

by Fourstar Group Inc.

THERA Plus 64431942B is a Class II device made by Fourstar Group Inc., cleared under FDA 510(k) K222472 on 30 Nov 2022 and listed in FDA GUDID since 27 Oct 2023 (UDI-DI 00049696186797), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

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

510(k) K222472

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00049696186797 UDI-DI Date27 Oct 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK222472 Date30 Nov 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K222472 decided 30 Nov 2022 Active
  • FDA GUDID UDI-DI 00049696186797 listed 27 Oct 2023 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0226-2026 FDA Class III initiated 25 Jul 2025

    Due to incorrect/lack of Unique Device Identifier (UDI) codes.

Timeline

3 dated events

  1. Cleared FDA 510(k) K222472
  2. Listed FDA GUDID 00049696186797
  3. Recall initiated FDA recalls Z-0226-2026

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
THERA Plus
Generic name
Manual blood lancing device, reusable
Model / reference
64431942B
Primary DI / UDI-DI
00049696186797
510(k) Number
FDA product code
QRL
GMDN term
Manual blood lancing device, reusable
Device class
Class II
Regulation number
878.4850
GUDID distribution status
In Commercial Distribution

Related devices

Category: Manual blood lancing device, reusable

Cleared under the same submission (K222472)

and 8 more cleared under K222472

Similar devices

Other devices filed under FDA product code QRL (Multiple Use Blood Lancet For Single Patient Use Only).

Other devices from Fourstar Group Inc.

See all devices from Fourstar Group Inc. →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)