Medical Precision BV: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Medical Precision BV” (first 2023, latest 2023), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 255 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 |
|---|---|---|
| 2023 | 1 | 255 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Medical Precision BV took a median 255 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 255 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QRN | Radiation Therapy Marking Device | 2 | 1 |
Review panels
- Radiology (2)
Most recent Medical Precision BV 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K222112 | Comfort Marker 2.0 | QRN | 2023-03-30 | 255 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN200041 | De Novo | Radiation Therapy Marking Device | 2021-12-10 |
Recalls
openFDA lists no recalls under a recalling firm named Medical Precision BV.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Medical Analysis Systems, Inc. (107 510(k)s)
- Medical Components, Inc. (63 510(k)s)
- Medical Advances, Inc. (57 510(k)s)
- Medical Diagnostic Technologies, Inc. (57 510(k)s)
- Medical Devices, Inc. (49 510(k)s)
- Medical Device Technologies, Inc. (46 510(k)s)
- Medical Specialties, Inc. (40 510(k)s)
- Medical Device Inspection Co., Inc. (30 510(k)s)
- Medical Engineering Corp. (28 510(k)s)
- Medical Data Electronics (27 510(k)s)
- Medical Graphics Corp. (25 510(k)s)
- Medical Innovations Corp. (24 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medical Precision BV?
FDA lists 1 510(k) clearance under the applicant name “Medical Precision BV” (first 2023, latest 2023), plus 1 De Novo decision, 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 Medical Precision BV?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medical Precision BV is 255 days.
Which FDA product codes appear under Medical Precision BV?
The most frequent FDA product codes under this applicant name are QRN (Radiation Therapy Marking Device, 2).
Next steps
- See all 1 Medical Precision BV clearances with predicates and recalls
- Run predicate analysis for product code QRN, Medical Precision BV'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.