Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JSW — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
39 daysmedian FDA review time
128 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K922768 | RAPID NFT, MODIFICATION | Biomerieux Vitek, Inc. | 1992-10-14 | 128 | 0 |
| K900517 | RAPID NF SYSTEM | Innovative Diagnostic Systems, Inc. | 1990-03-13 | 39 | 0 |
| K870769 | AUSTIN NONFERMENTER KIT | Austin Biological Laboratories | 1987-04-03 | 36 | 0 |
| K790992 | PSEUDO-PALETTE TM | Micro-Palettes, Inc. | 1979-06-22 | 24 | 0 |
| K772112 | NON-FERMENTER SYSTEM | Corning Medical & Scientific | 1977-11-17 | 10 | 0 |
| K770745 | PANEL, GNF, MICRO-ID | Micro-Media Systems, Inc. | 1977-06-23 | 62 | 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