Bk Medical Aps: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Bk Medical Aps” (first 2015, latest 2023), across 1 product code in 1 review panel. Median 510(k) review time under this name: 95 days. Since 2017 the median was 117 days, against 101 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under GE HealthCare, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 3 | 60 |
| 2016 | 1 | 91 |
| 2017 | 0 | — |
| 2018 | 2 | 114 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 117 |
| 2023 | 2 | 120 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Bk Medical Aps took a median 117 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 101 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 9 | 9 |
Review panels
- Radiology (9)
Most recent Bk Medical Aps 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231764 | Ultrasound System 1300 | IYN | 2023-10-23 | 129 |
| K223830 | Ultrasound System 2300 | IYN | 2023-04-11 | 111 |
| K222441 | Ultrasound System 2300 | IYN | 2022-12-07 | 117 |
| K180737 | Ultrasound Scanner System bk2300 | IYN | 2018-08-01 | 132 |
| K173569 | Ultrasound System 1300 | IYN | 2018-02-23 | 95 |
| K161960 | bk2300 | IYN | 2016-10-17 | 91 |
| K151910 | Ultrasound Scanner System BK2300 | IYN | 2015-10-05 | 84 |
| K152052 | Ultrasound Scanner System bk2300 | IYN | 2015-09-16 | 55 |
| K143298 | Ultrasound Scanner System bk2300 | IYN | 2015-01-16 | 60 |
Recalls
openFDA lists no recalls under a recalling firm named Bk 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 Bk Medical Aps?
FDA lists 9 510(k) clearances under the applicant name “Bk Medical Aps” (first 2015, latest 2023), across 1 product code 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 Bk Medical Aps?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bk Medical Aps is 95 days. Since 2017: 117 days, versus 101 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Bk Medical Aps?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 9).
Next steps
- See all 9 Bk Medical Aps clearances with predicates and recalls
- Run predicate analysis for product code IYN, Bk 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.