B-K Medical Aps: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “B-K Medical Aps” (first 2007, latest 2014), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 118 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 | 1 | 118 |
| 2014 | 5 | 132 |
| 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 | 5 | 5 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 4 | 4 |
| FCG | Biopsy Needle | 1 | 1 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
Review panels
Most recent B-K Medical Aps 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K140428 | ULTRASOUND SCANNER SYSTEM BK2300 | IYO | 2014-05-30 | 100 |
| K132346 | ULTRASOUND SCANNER PRO FOCUS 2202 | IYO | 2014-01-10 | 165 |
| K132335 | ULTRASOUND SCANNER FLEX FOCUS 1202 | IYN | 2014-01-10 | 168 |
| K132677 | ULTRASOUND SCANNER FLEX FOCUS 1202 | IYN | 2014-01-07 | 132 |
| K132685 | ULTRASOUND SCANNER PRO FOCUS 2202 | IYN | 2014-01-06 | 131 |
| K123254 | ULTRASOUND SCANNER FLEX FOCUS | IYN | 2013-02-13 | 118 |
| K100919 | PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202 | IYN | 2011-12-16 | 623 |
| K083667 | NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337 | ITX | 2009-02-02 | 53 |
| K081323 | BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818 | FCG | 2008-07-22 | 71 |
| K081154 | ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202 | IYO | 2008-05-23 | 30 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named B-K Medical Aps.
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 Aps?
FDA lists 11 510(k) clearances under the applicant name “B-K Medical Aps” (first 2007, latest 2014), across 4 product codes in 2 review panels. 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 Aps?
The median time from FDA receipt to decision across 510(k)s cleared under the name B-K Medical Aps is 118 days.
Which FDA product codes appear under B-K Medical Aps?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 5); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 4); FCG (Biopsy Needle, 1).
Next steps
- See all 11 B-K Medical Aps clearances with predicates and recalls
- Run predicate analysis for product code IYN, B-K Medical Aps'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.