Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biocompatibles UK Limited · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
114 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K162373 | LC Bead LUMI | Biocompatibles UK Limited | 2016-12-16 | 114 | 0 |
| K094018 | LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES | Biocompatibles UK Limited | 2010-04-16 | 108 | 0 |
| K083091 | LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES | Biocompatibles UK Limited | 2008-12-24 | 68 | 0 |
| K042231 | GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPH | Biocompatibles UK Limited | 2004-11-12 | 87 | 0 |
| K033761 | GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES | Biocompatibles UK Limited | 2004-02-04 | 64 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda