Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
MRB · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K081879 | SPSMEDICAL SPORVIEW PA CULTURE SET | Spsmedical Supply Corp. | 2008-07-30 | 28 | 0 |
| K053212 | RAVEN PROPACT | Raven Biological Laboratories, Inc. | 2006-02-15 | 91 | 0 |
| K043135 | SPSMEDICAL SPORVIEW PA CULTURE SET | Spsmedical Supply Corp. | 2005-01-13 | 62 | 0 |
| K031114 | PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA | Raven Biological Laboratories, Inc. | 2004-03-03 | 330 | 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