Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bioplexus Corp. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K952732 | MEDICAL GRADE SILICONE BLOCK | Bioplexus Corp. | 1995-08-31 | 77 | 0 |
| K933827 | BIOSIL MEDICAL GRADE SILICONE SHEETING FOR OBSTETRICAL & GYN | Bioplexus Corp. | 1994-06-30 | 329 | 0 |
| K932176 | BIOSIL MEDICAL GRADE SILICONE SHEETING | Bioplexus Corp. | 1993-12-02 | 211 | 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