Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Chemtrak, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
146 daysmedian FDA review time
515 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972495 | ACCUMETER THEOPHYLLINE TEST | Chemtrak, Inc. | 1997-10-10 | 99 | 0 |
| K965099 | ACCUMETER H. PYLORI TEST | Chemtrak, Inc. | 1997-02-20 | 62 | 1 |
| K960478 | ACCUMETER H. PYLORI TEST | Chemtrak, Inc. | 1996-06-27 | 146 | 0 |
| K943279 | ACCUMETER HDL CHOLESTEROL TEST | Chemtrak, Inc. | 1995-05-01 | 298 | 0 |
| K943599 | CHEM TRAK ACCUMETER | Chemtrak, Inc. | 1995-03-21 | 258 | 0 |
| K914432 | ACCUMETER(R) CHOLESTEROL SELF-TEST | Chemtrak, Inc. | 1993-03-02 | 515 | 0 |
| K905405 | CHEMTRAK ACCUMETER CHOLESTEROL TEST | Chemtrak, Inc. | 1991-03-19 | 106 | 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