B-K Medical A/S: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “B-K Medical A/S” (first 2001, latest 2005), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 25 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 4 | 4 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 3 | 3 |
Review panels
- Radiology (7)
Most recent B-K Medical A/S 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K043554 | ULTRASOUND SCANNER MINI FOCUS, MODEL 1402 | IYN | 2005-01-14 | 18 |
| K043524 | ULTRASOUND SCANNER PRO FOCUS, MODEL 2202 | IYN | 2005-01-13 | 24 |
| K024236 | ULTRASOUND SCANNER, TYPE 2400 | IYN | 2003-01-17 | 25 |
| K023457 | ULTRASOUND SCANNER, TYPE 1101 | IYO | 2002-11-01 | 17 |
| K011417 | ULTRASOUND SCANNER, TYPE 2102 | IYO | 2001-06-08 | 30 |
| K003986 | ULTRASOUND SCANNER TYPE 2102 | IYN | 2001-04-03 | 98 |
| K003041 | ULTRASOUND SCANNER TYPE 2101 | IYO | 2001-02-07 | 131 |
Recalls
9 product recalls in 4 recall events; 8 initiated in the last five years. Most recent: 2025-10-09.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under B-K Medical A/S?
FDA lists 7 510(k) clearances under the applicant name “B-K Medical A/S” (first 2001, latest 2005), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by B-K Medical A/S?
The median time from FDA receipt to decision across 510(k)s cleared under the name B-K Medical A/S is 25 days.
Which FDA product codes appear under B-K Medical A/S?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 4); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 3).
Next steps
- See all 7 B-K Medical A/S clearances with predicates and recalls
- Run predicate analysis for product code IYN, B-K Medical A/S's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.