# B-K Medical Aps

- Location (FDA's records): Herlev, DK
- FDA decisions: 15 (1981–2014): 15 510(k) clearances
- Names in FDA's records: B-K Medical Aps (11); B&K Medical (4)
- Product codes: IYO (7), IYN (5), ITX (1), FCG (1), KOD (1)
- Predicates its devices cite: 17 (5 its own); citations of its devices by later devices: 19 (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 A/S: 3 (https://510kreport.com/company/b-k-medical-a-s)
- Zonare Medical Systems, Inc.: 2 (https://510kreport.com/company/zonare-medical-systems)
- Philips Ultrasound, Inc.: 2 (https://510kreport.com/company/philips-ultrasound)
- Toshiba Medical Systems Coporation, Japan: 2 (https://510kreport.com/company/toshiba-medical-systems-coporation-japan)
- Sheathing Technologies, Inc.: 1 (https://510kreport.com/company/sheathing-technologies)
- Envisioneering, LLC: 1 (https://510kreport.com/company/envisioneering)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)

## Firms that cite its devices most
- Bk Medical Aps: 3 (https://510kreport.com/company/bk-medical)
- CIVCO Medical Instruments Co., Inc.: 3 (https://510kreport.com/company/civco-medical-instruments)
- Carestream Health, Inc.: 2 (https://510kreport.com/company/carestream-health)
- Analogic Corp.: 2 (https://510kreport.com/company/analogic)
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-mindray-bio-medical-electronics)
- Oreon Technologies, Inc.: 1 (https://510kreport.com/company/oreon-technologies)
- B-K Medical A/S: 1 (https://510kreport.com/company/b-k-medical-a-s)
- Exact Imaging, Inc.: 1 (https://510kreport.com/company/exact-imaging)

## Its most-cited devices
- K100919: Pro Focus 2202, Pro Focus 2202 UV Model: Type 2202 (2011), cited by 5
- K081154: Ultrasound Scanner Flex Focus, Model 1202 (2008), cited by 4
- K140428: Ultrasound Scanner System BK2300 (2014), cited by 2
- K943315: Ultrasound Scanner 2002 (1996), cited by 2
- K123254: Ultrasound Scanner Flex Focus (2013), cited by 2
- K083667: Needle Guide for 8814, Model UA1335, Needle Guide for 8815, Model UA 1336, Needle Guide for 8824, Model UA 1337 (2009), cited by 1

## Recent decisions
- K140428: Ultrasound Scanner System BK2300 (May 30, 2014)
- K132335: Ultrasound Scanner Flex Focus 1202 (Jan 10, 2014)
- K132346: Ultrasound Scanner Pro Focus 2202 (Jan 10, 2014)
- K132677: Ultrasound Scanner Flex Focus 1202 (Jan 7, 2014)
- K132685: Ultrasound Scanner Pro Focus 2202 (Jan 6, 2014)
- K123254: Ultrasound Scanner Flex Focus (Feb 13, 2013)
- K100919: Pro Focus 2202, Pro Focus 2202 UV Model: Type 2202 (Dec 16, 2011)
- K083667: Needle Guide for 8814, Model UA1335, Needle Guide for 8815, Model UA 1336, Needle Guide for 8824, Model UA 1337 (Feb 2, 2009)

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