Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Anarobe Systems — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
14 daysmedian FDA review time
28 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K842850 | TRIPLE SUGAR IRON | Anarobe Systems | 1984-08-17 | 28 | 0 |
| K842854 | MUELLER HINTON BROTH | Anarobe Systems | 1984-08-17 | 28 | 0 |
| K842851 | ORNITHINE INDOLE MOTILITY | Anarobe Systems | 1984-08-07 | 18 | 0 |
| K842852 | BRAIN HEART INFUSION BROTH | Anarobe Systems | 1984-08-03 | 14 | 0 |
| K842853 | LYSINE IRON AGAR | Anarobe Systems | 1984-08-03 | 14 | 0 |
| K842849 | TRYPTICASE SOY BROTH | Anarobe Systems | 1984-08-03 | 14 | 0 |
| K842855 | CHRISTENSEN'S UREA AGAR | Anarobe Systems | 1984-08-03 | 14 | 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