Ultrasound System 2300
FDA 510(k) clearance K223830 · decided 2023-04-11
Clearance details
- K-number
- K223830
- Device name
- Ultrasound System 2300
- Applicant
- Bk Medical Aps
- Decision
- Substantially Equivalent
- Date received
- 2022-12-21
- Decision date
- 2023-04-11
- Days to decision
- 111 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Herlev, DK
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Dop recall (Z-0437-2026) | B-K Medical A/S | 2025-11-06 |
| bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ul recall (Z-0438-2026) | B-K Medical A/S | 2025-11-06 |
| bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ul recall (Z-0439-2026) | B-K Medical A/S | 2025-11-06 |
| bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ul recall (Z-0440-2026) | B-K Medical A/S | 2025-11-06 |
| bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, recall (Z-0136-2025) | B-K Medical A/S | 2024-10-18 |
| bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66. recall (Z-0813-2024) | B-K Medical A/S | 2024-01-25 |