# Bk Medical Aps

- Location (FDA's records): Herlev, DK
- FDA decisions: 9 (2015–2023): 9 510(k) clearances
- Product codes: IYN (9)
- 510(k) review time since 2016: median 114 days, against 95 for FDA's reviews in the same codes and years (1 of 6 faster)
- Predicates its devices cite: 14 (7 its own); citations of its devices by later devices: 7 (7 its own)
- Recalls linked to its devices: 8 (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: 3 (https://510kreport.com/company/b-k-medical)
- Toshiba America Medical Systems, In.C: 2 (https://510kreport.com/company/toshiba-america-medical-systems-in-c)
- B-K Medical A/S: 1 (https://510kreport.com/company/b-k-medical-a-s)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)

## Its most-cited devices
- K161960: bk2300 (2016), cited by 2
- K222441: Ultrasound System 2300 (2022), cited by 1
- K173569: Ultrasound System 1300 (2018), cited by 1
- K180737: Ultrasound Scanner System bk2300 (2018), cited by 1
- K143298: Ultrasound Scanner System bk2300 (2015), cited by 1
- K151910: Ultrasound Scanner System BK2300 (2015), cited by 1

## Recent decisions
- K231764: Ultrasound System 1300 (Oct 23, 2023)
- K223830: Ultrasound System 2300 (Apr 11, 2023)
- K222441: Ultrasound System 2300 (Dec 7, 2022)
- K180737: Ultrasound Scanner System bk2300 (Aug 1, 2018)
- K173569: Ultrasound System 1300 (Feb 23, 2018)
- K161960: bk2300 (Oct 17, 2016)
- K151910: Ultrasound Scanner System BK2300 (Oct 5, 2015)
- K152052: Ultrasound Scanner System bk2300 (Sep 16, 2015)

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