Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GJR — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
36 daysmedian FDA review time
371 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K080016 | NRBC-CHEX FOR ADVIA | Streck | 2008-02-05 | 33 | 0 |
| K060083 | NRBC-CHEX FOR LH | Streck | 2006-02-09 | 29 | 0 |
| K000076 | CELL-CHEX | Streck Laboratories, Inc. | 2000-03-03 | 53 | 0 |
| K940430 | SEDRATROL | Medical Specialties Intl., Inc. | 1995-02-06 | 371 | 0 |
| K900484 | RET-CHECK | Streck Laboratories, Inc. | 1990-03-09 | 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