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Wireless Remote Control UA2361

by Bk Medical ApS

Wireless Remote Control UA2361 is a Class II device made by Bk Medical ApS, cleared under FDA 510(k) K223830 on 11 Apr 2023 and listed in FDA GUDID since 7 May 2025 (UDI-DI 05704916000318), 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

6 ongoing

Recall on shared 510(k) K223830; other models may be affected

Documents

510(k) K223830

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 Number05704916000318 UDI-DI Date7 May 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK223830 Date11 Apr 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K223830 decided 11 Apr 2023 Active
  • FDA GUDID UDI-DI 05704916000318 listed 7 May 2025 Listed

Recalls

6 recalls · 6 ongoing · FDA

  • 4 recalls, same reason

    • Ongoing Z-0437-2026 FDA Class II initiated 9 Oct 2025 on shared 510(k) K223830
    • Ongoing Z-0440-2026 FDA Class II initiated 9 Oct 2025 on shared 510(k) K223830
    • Ongoing Z-0438-2026 FDA Class II initiated 9 Oct 2025 on shared 510(k) K223830
    • Ongoing Z-0439-2026 FDA Class II initiated 9 Oct 2025 on shared 510(k) K223830

    GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.

    • Ongoing Z-0136-2025 FDA Class II initiated 4 Sep 2024 on shared 510(k) K223830

    The internal power connections at the power inlet of the ultrasound devices can come loose resulting in the potential for excessive heat which could lead to a thermal event or the device becoming inoperable.

    • Ongoing Z-0813-2024 FDA Class II initiated 30 Nov 2023 on shared 510(k) K223830

    An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error.

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

Timeline

8 dated events

  1. Cleared FDA 510(k) K223830
  2. Recall initiated FDA recalls Z-0813-2024
  3. Recall initiated FDA recalls Z-0136-2025
  4. Listed FDA GUDID 05704916000318
  5. Recall initiated FDA recalls Z-0437-2026
  6. Recall initiated FDA recalls Z-0440-2026
  7. Recall initiated FDA recalls Z-0438-2026
  8. Recall initiated FDA recalls Z-0439-2026

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Wireless Remote Control
Generic name
Diagnostic radiography device remote control
Model / reference
UA2361
Primary DI / UDI-DI
05704916000318
510(k) Number
FDA product code
ITX
GMDN term
Diagnostic radiography device remote control
Device class
Class II
Regulation number
892.1570
GUDID distribution status
In Commercial Distribution

Related devices

Category: Diagnostic radiography device remote control

Cleared under the same submission (K223830)

and 4 more cleared under K223830

Similar devices

Also classified as Diagnostic radiography device remote control.

Similar devices

Other devices filed under FDA product code ITX (Transducer, Ultrasonic, Diagnostic).

Other devices from Bk Medical ApS

See all devices from Bk Medical ApS →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)