Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
CFD · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K863073 | TOTAL LIPIDS | J. D. Assoc. | 1986-09-09 | 28 | 0 |
| K860112 | TOTAL LIPIDS REAGENT SET | Technostics Intl. | 1986-01-24 | 11 | 0 |
| K820500 | TOTAL LIPID REAGENT SET | Anco Medical Reagents & Assoc. | 1982-03-11 | 16 | 0 |
| K813469 | LIPID PROFILE | Bio-Analytics Laboratories, Inc. | 1981-12-31 | 20 | 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