Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
JSQ · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K834007 | CYSTINE TRYPTIC MEDIUM | Micro Media Laboratories | 1983-12-22 | 31 | 0 |
| K811138 | NUTRIENT AGAR | Acumedia Manufacturers, Inc. | 1981-05-05 | 11 | 0 |
| K761226 | GP3%SP-2100DOHON100/120 MESH SUPELCOPORT | Supelco, Inc. | 1977-01-14 | 36 | 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