Skip to content

THERA Plus 64431942AA

by Fourstar Group Inc.

THERA Plus 64431942AA 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 00049696186773), active as of 23 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

1 ongoing

Recall on shared 510(k) K222472; other models may be affected

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 Number00049696186773 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 00049696186773 listed 27 Oct 2023 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0226-2026 FDA Class III initiated 25 Jul 2025 on shared 510(k) K222472

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

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

3 dated events

  1. Cleared FDA 510(k) K222472
  2. Listed FDA GUDID 00049696186773
  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  • Withdrawn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
Blood lancing device tip
Model / reference
64431942AA
Primary DI / UDI-DI
00049696186773
510(k) Number
FDA product code
QRK
GMDN term
Blood lancing device tip
Device class
Class II
Regulation number
878.4850
GUDID distribution status
In Commercial Distribution
Sterilisation method
Radiation Sterilization

Related devices

Category: Blood lancing device tip

Cleared under the same submission (K222472)

and 8 more cleared under K222472

Similar devices

Other devices filed under FDA product code QRK (Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature).

Other devices from Fourstar Group Inc.

See all devices from Fourstar Group Inc. →

Properties

  • Supplied sterile
  • Sterilise before use
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)