Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Timex Medical Products Corp. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
35 daysmedian FDA review time
110 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K841616 | TIMEX HEALTHCHECK DIGITAL BP MONITOR | Timex Medical Products Corp. | 1984-06-05 | 35 | 0 |
| K841595 | HEALTHCHECK HOME PREGNANCY TEST KIT | Timex Medical Products Corp. | 1984-05-31 | 43 | 0 |
| K840228 | HEALTHCHECK AUTO INFLATE DIGITAL BP | Timex Medical Products Corp. | 1984-05-09 | 110 | 0 |
| K821437 | DIGITAL BLOOD PRESSURE METER | Timex Medical Products Corp. | 1982-05-28 | 15 | 0 |
| K821436 | ELECTRONIC DIGITAL THERMOMETER | Timex Medical Products Corp. | 1982-05-27 | 14 | 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