Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KYA · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
110 daysmedian FDA review time
312 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K900404 | VARICOSCREEN(TM) | Promedex, Inc. | 1990-12-07 | 312 | 0 |
| K832989 | BREAST THERMAL ACTIVITY INDICATOR | Bcsi Laboratories, Inc. | 1984-01-17 | 138 | 0 |
| K823245 | THERMAX; THERMAX SYSTEM | American Thermometer Company, Inc. | 1982-11-16 | 15 | 0 |
| K821524 | CHIROPRATIC INFRA-RED CRYSTAL PAK | Dr. John D. Reid B.A., D.C. | 1982-09-08 | 110 | 0 |
| K821049 | PARATHERM | American Thermometer Company, Inc. | 1982-04-29 | 23 | 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