Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
DAA · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
34 daysmedian FDA review time
150 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K832675 | ANA MICROZYME TEST SYS #1610 | Clinical Sciences, Inc. | 1983-09-12 | 34 | 0 |
| K831927 | ANTINUCLEAR ANTIBODY TEST KIT | Breit Laboratories, Inc. | 1983-07-18 | 33 | 0 |
| K830005 | IP SPECIFIC G | Diagnostic Reagent Tech. | 1983-06-02 | 150 | 0 |
| K822911 | ANAZYME ANA PEROXIDASE TEST SYSTEM | Clinical Sciences, Inc. | 1982-10-22 | 21 | 0 |
| K791749 | INDIRECT IMMUNO ENZYME,ANTIGEN,CONTROL | Clinical Sciences, Inc. | 1979-10-17 | 37 | 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