Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Culture Kits, Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
232 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K911846 | URI-THREE(TM), MODIFICATION | Culture Kits, Inc. | 1991-10-04 | 169 | 0 |
| K854672 | CANDI-KIT TM | Culture Kits, Inc. | 1986-07-11 | 232 | 0 |
| K853488 | STAPH KIT | Culture Kits, Inc. | 1985-08-28 | 8 | 0 |
| K851225 | URINE DUO | Culture Kits, Inc. | 1985-08-13 | 140 | 0 |
| K852582 | GONI-KIT | Culture Kits, Inc. | 1985-07-12 | 24 | 0 |
| K852480 | DERM-KIT | Culture Kits, Inc. | 1985-07-09 | 28 | 0 |
| K851518 | MUELLER HINTON SENSITIVITY PLATE | Culture Kits, Inc. | 1985-04-29 | 14 | 0 |
| K850765 | STREP-KIT | Culture Kits, Inc. | 1985-04-24 | 58 | 0 |
| K850998 | URI-KIT | Culture Kits, Inc. | 1985-04-01 | 21 | 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