Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sen Tech Medical Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
80 daysmedian FDA review time
112 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K910071 | PORTA GAS COMPRESSED GAS CYLINDER CART | Sen Tech Medical Corp. | 1991-03-22 | 72 | 0 |
| K855091 | CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS | Sen Tech Medical Corp. | 1986-03-14 | 84 | 0 |
| K854260 | CHEMPRO 1000 | Sen Tech Medical Corp. | 1985-11-19 | 27 | 0 |
| K851100 | CHEM PRO 1000 CHEMISTRY ANALYSIS | Sen Tech Medical Corp. | 1985-07-09 | 112 | 0 |
| K841575 | SENTECH'S ULAB 1000 CLINICAL CHEM. | Sen Tech Medical Corp. | 1984-07-06 | 80 | 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