Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KQN — Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
93 daysmedian FDA review time
182 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K041657 | THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) | Thermo Electron Corporation | 2004-08-30 | 73 | 0 |
| K942497 | ANGIOTENSIN CONVERTING ENZYME REA | American Laboratory Products Co., Ltd. | 1994-11-15 | 182 | 0 |
| K913091 | BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY | American Laboratory Products Co., Ltd. | 1991-08-26 | 45 | 0 |
| K854876 | ALDOSTERONE DIRECT RIA KIT | Biotecx Laboratories, Inc. | 1986-03-17 | 101 | 0 |
| K854245 | SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UV | Sigma Diagnostics, Inc. | 1986-01-22 | 93 | 0 |
| K833933 | ACE COLOR TEST | Hana Biologics, Inc. | 1984-03-23 | 130 | 0 |
| K821011 | ACE ACTIVITY MICROVIAL TEST SET | Ventrex Laboratories, Inc. | 1982-05-03 | 21 | 0 |
| K791712 | ANGIOTENSIN CONVERTING ENZYME ASSAY SYS | Ventrex Laboratories, Inc. | 1979-09-19 | 50 | 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