Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JSL · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
51 daysmedian FDA review time
240 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972449 | COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL | Copan Italia Spa | 1997-08-20 | 51 | 0 |
| K972448 | COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL | Copan Italia Spa | 1997-08-20 | 51 | 0 |
| K944847 | KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEM | Starplex Scientific, Inc. | 1995-02-16 | 139 | 0 |
| K925450 | BIONOR TRANSPORTMEDIUM | Skoug Research Corp. | 1993-06-25 | 240 | 0 |
| K841220 | ANAEROBIC TRANSPORT MEDIUM | Anaerobe Systems | 1984-04-04 | 13 | 0 |
| K834357 | ANA TRANS TUBE & SWABS STERILE PACK | Anaerobe Systems | 1984-01-31 | 49 | 0 |
| K770840 | PRE-REDUCED ANAEROBIC MEDIA | Gibco Laboratories Life Technologies, Inc. | 1977-06-08 | 30 | 0 |
| K770650 | PRE-DUCED CULTURE MEDIA | Gibco Laboratories Life Technologies, Inc. | 1977-04-15 | 9 | 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