Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CIA — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
45 daysmedian FDA review time
203 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K870369 | CALCIUM REAGENT-METHYL THYMOL BLUE METHOD | Trace Scientific , Ltd. | 1987-08-19 | 203 | 0 |
| K863059 | CALCIOMETER | J. D. Assoc. | 1986-09-26 | 45 | 0 |
| K822898 | DSL 1600 | Diagnostic Systems Laboratories, Inc. | 1982-12-09 | 71 | 0 |
| K792396 | ELVI CALCIUM | Volu Sol Medical Industries | 1979-12-06 | 10 | 0 |
| K771468 | MULTISTAT III CALCIUM TEST | Instrumentation Laboratory CO | 1977-09-12 | 39 | 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