# B-K Medical A/S

- Location (FDA's records): Dk 2820 Gentofte, DK
- FDA decisions: 11 (1995–2005): 11 510(k) clearances
- Names in FDA's records: B-K Medical A/S (7); B & K Medical A/S (4)
- Product codes: IYO (7), IYN (4)
- Predicates its devices cite: 7 (5 its own); citations of its devices by later devices: 12 (5 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- B-K Medical Aps: 1 (https://510kreport.com/company/b-k-medical)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)

## Firms that cite its devices most
- B-K Medical Aps: 3 (https://510kreport.com/company/b-k-medical)
- CIVCO Medical Instruments Co., Inc.: 1 (https://510kreport.com/company/civco-medical-instruments)
- Carestream Health, Inc.: 1 (https://510kreport.com/company/carestream-health)
- Ultrasound Medical Devices, Inc.: 1 (https://510kreport.com/company/ultrasound-medical-devices)
- Bk Medical Aps: 1 (https://510kreport.com/company/bk-medical)

## Its most-cited devices
- K043524: Ultrasound Scanner Pro Focus, Model 2202 (2005), cited by 5
- K024236: Ultrasound Scanner, Type 2400 (2003), cited by 3
- K936024: Ultrasound Scanner 2001 (1995), cited by 1
- K000567: Ultrasound Scanner Type 2102 (2000), cited by 1
- K011417: Ultrasound Scanner, Type 2102 (2001), cited by 1
- K003986: Ultrasound Scanner Type 2102 (2001), cited by 1

## Recent decisions
- K043554: Ultrasound Scanner Mini Focus, Model 1402 (Jan 14, 2005)
- K043524: Ultrasound Scanner Pro Focus, Model 2202 (Jan 13, 2005)
- K024236: Ultrasound Scanner, Type 2400 (Jan 17, 2003)
- K023457: Ultrasound Scanner, Type 1101 (Nov 1, 2002)
- K011417: Ultrasound Scanner, Type 2102 (Jun 8, 2001)
- K003986: Ultrasound Scanner Type 2102 (Apr 3, 2001)
- K003041: Ultrasound Scanner Type 2101 (Feb 7, 2001)
- K002085: Ultrasound Scanner, Type 1101 (Aug 1, 2000)

Source page: https://510kreport.com/company/b-k-medical-a-s