Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Island Biosurgical, Inc. · 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) |
|---|---|---|---|---|---|
| K982042 | ISLAND BIOSURGICAL BLADDER NECK BOLSTR MODEL IBIBOL.002 | Island Biosurgical, Inc. | 1998-09-08 | 90 | 0 |
| K973022 | ISLAND BIOSURGICAL INC. BNS KIT #1 & #2 | Island Biosurgical, Inc. | 1997-10-20 | 67 | 0 |
| K960101 | ISLAND BIOSURGICAL BOLSTER | Island Biosurgical, Inc. | 1996-12-16 | 340 | 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