Biocompatibles UK Limited: FDA clearances and approvals
Biocompatibles UK Limited has 5 FDA 510(k) clearances (first 2004, latest 2016), across 2 product codes in 2 review panels. Median 510(k) review time: 87 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 114 |
| 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 |
|---|---|---|---|
| HCG | Device, Neurovascular Embolization | 3 | 3 |
| KRD | Device, Vascular, For Promoting Embolization | 2 | 2 |
Review panels
- Neurology (3)
- Cardiovascular (2)
Most recent Biocompatibles UK Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K162373 | LC Bead LUMI | KRD | 2016-12-16 | 114 |
| K094018 | LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES | HCG | 2010-04-16 | 108 |
| K083091 | LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES | KRD | 2008-12-24 | 68 |
| K042231 | GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES | HCG | 2004-11-12 | 87 |
| K033761 | GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES | HCG | 2004-02-04 | 64 |
Recalls
openFDA lists no recalls under a recalling firm named Biocompatibles UK Limited.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Biocompatibles UK Limited have?
Biocompatibles UK Limited has 5 FDA 510(k) clearances (first 2004, latest 2016), across 2 product codes in 2 review panels.
How long does FDA take to clear Biocompatibles UK Limited's 510(k)s?
The median time from FDA receipt to decision across Biocompatibles UK Limited's cleared 510(k)s is 87 days.
What devices does Biocompatibles UK Limited make?
Its most frequent FDA product codes are HCG (Device, Neurovascular Embolization, 3); KRD (Device, Vascular, For Promoting Embolization, 2).
Has Biocompatibles UK Limited had device recalls?
openFDA lists no recalls under a recalling firm name matching Biocompatibles UK Limited. Related entities may recall under other names.
Next steps
- See all 5 Biocompatibles UK Limited clearances with predicates and recalls
- Run predicate analysis for product code HCG, Biocompatibles UK Limited's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.