510(k) K223830 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Ultrasound System 2300
| Applicant | Bk Medical Aps, Herlev, DK |
| Decision | Substantially Equivalent, Apr 11, 2023 |
| Received | Dec 21, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223830
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2025 | B-K Medical A/S UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic Open, Classified |
IYN | None listed |
| Nov 6, 2025 | B-K Medical A/S bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic Open, Classified |
IYN | None listed |
| Nov 6, 2025 | B-K Medical A/S bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic Open, Classified |
IYN | None listed |
| Nov 6, 2025 | B-K Medical A/S bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic Open, Classified |
IYN | None listed |
| Oct 18, 2024 | B-K Medical A/S bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery option. Open, Classified |
IYN | None listed |
| Jan 25, 2024 | B-K Medical A/S bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66. Open, Classified |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.