Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
CIS · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
41 daysmedian FDA review time
109 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K032027 | CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST) | Cholestech Corp. | 2003-09-05 | 66 | 1 |
| K896238 | COBAS READY AST REAGENT | Roche Diagnostic Systems, Inc. | 1990-02-16 | 109 | 0 |
| K854187 | IN-VITRO TEST DETERMINATION OF SGOT (AST) | Clinical Data, Inc. | 1985-11-25 | 41 | 0 |
| K812872 | OPTIONAL TOTAL CA-MODULE FOR IL 504/508 | Instrumentation Laboratory CO | 1981-10-26 | 12 | 0 |
| K792410 | ELVI SGOT & SGPT TRANSAMINASE | Volu Sol Medical Industries | 1979-12-06 | 10 | 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