B-K Medical A/S
FDA Regulatory Profile
B-K Medical A/S appears in FDA public data with 9 recalls, 7 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0437-2026, Class II) was initiated on October 9, 2025. Its most recent 510(k) clearance was granted on January 14, 2005.
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 7
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0437-2026 | Class II | UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultr | October 9, 2025 |
| Z-0438-2026 | Class II | bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic | October 9, 2025 |
| Z-0435-2026 | Class II | 1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex | October 9, 2025 |
| Z-0436-2026 | Class II | Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Do | October 9, 2025 |
| Z-0439-2026 | Class II | bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic | October 9, 2025 |
| Z-0440-2026 | Class II | bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic | October 9, 2025 |
| Z-0136-2025 | Class II | bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #23 | September 4, 2024 |
| Z-0813-2024 | Class II | bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66. | November 30, 2023 |
| Z-2325-2016 | Class II | BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2 | June 28, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K043554 | ULTRASOUND SCANNER MINI FOCUS, MODEL 1402 | January 14, 2005 |
| K043524 | ULTRASOUND SCANNER PRO FOCUS, MODEL 2202 | January 13, 2005 |
| K024236 | ULTRASOUND SCANNER, TYPE 2400 | January 17, 2003 |
| K023457 | ULTRASOUND SCANNER, TYPE 1101 | November 1, 2002 |
| K011417 | ULTRASOUND SCANNER, TYPE 2102 | June 8, 2001 |
| K003986 | ULTRASOUND SCANNER TYPE 2102 | April 3, 2001 |
| K003041 | ULTRASOUND SCANNER TYPE 2101 | February 7, 2001 |