Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
DID · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
16 daysmedian FDA review time
66 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K820773 | EMIT-ST URINE COCAINE METABOLITE ASSAY | Syva Co. | 1982-04-08 | 16 | 0 |
| K802038 | PHENYTOIN REAGENT TEST KIT | Beckman Instruments, Inc. | 1980-10-23 | 59 | 0 |
| K780950 | BIO-MONITOR TOBRAMYCIN | Monitor Science Corp. | 1978-08-14 | 66 | 0 |
| K780182 | TOBRAMYCIN 125I RIA KIT | New England Nuclear | 1978-02-13 | 10 | 0 |
| K780048 | AMINOGLYCOSIDE TEST SYSTEM | Nichols Institute Diagnostics | 1978-01-20 | 11 | 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