Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
CHD · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K841052 | CHOLESTEROL REAGENT SET | Medical Specialties, Inc. | 1984-05-01 | 50 | 0 |
| K830616 | ACTIVATED URIC ACID | American Monitor Corp. | 1983-04-05 | 36 | 0 |
| K821195 | CHOLESTEROL REAGENT SET | Omega Medical Electronics | 1982-07-13 | 77 | 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