Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biolog, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
35 daysmedian FDA review time
87 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K850750 | DISPOSABLE UROSTOMY POUCH | Biolog, Inc. | 1985-05-23 | 87 | 0 |
| K850751 | DISPOS. DRAINABEL POUCH FOR ILEOSTOMY/COLOSTOMY | Biolog, Inc. | 1985-05-23 | 87 | 0 |
| K811282 | SELECTIVE GC CULTURE MEDIUM | Biolog, Inc. | 1981-06-12 | 35 | 0 |
| K811281 | GC CULTURE MEDIUM | Biolog, Inc. | 1981-06-12 | 35 | 0 |
| K811284 | GC TTANSPORT SYSTEM | Biolog, Inc. | 1981-06-12 | 35 | 0 |
| K811283 | JEMBEC TRANSPORT SYSTEM | Biolog, Inc. | 1981-06-12 | 35 | 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