Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Exocell, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
157 daysmedian FDA review time
173 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K980888 | GLYCACOR | Exocell, Inc. | 1998-08-13 | 157 | 0 |
| K894423 | ACC.U.DIAL | Exocell, Inc. | 1989-12-27 | 163 | 0 |
| K893453 | GLYCABEN | Exocell, Inc. | 1989-10-23 | 173 | 0 |
| K891544 | DIALBUMIN | Exocell, Inc. | 1989-06-09 | 84 | 0 |
| K884146 | ALBUWELL | Exocell, Inc. | 1989-01-23 | 112 | 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