Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sensortek, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
83 daysmedian FDA review time
104 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K864345 | NTE-2 THERMAL SENSITIVITY TESTER | Sensortek, Inc. | 1987-01-29 | 86 | 0 |
| K863607 | VIBRATRON II, VIBRATION SENSITIVITY TESTER | Sensortek, Inc. | 1986-12-03 | 78 | 0 |
| K852228 | ESOPHAGEAL STETHOSCOPE WITH ELECTRICAL CONDUCTORS | Sensortek, Inc. | 1985-09-03 | 104 | 0 |
| K844056 | THERMOCOUPLE SENSORS, ACCESS. FOR ELECTRONIC THERM | Sensortek, Inc. | 1985-01-09 | 83 | 0 |
| K844055 | ESOPHAGEAL STETHO SCOPE | Sensortek, Inc. | 1984-10-25 | 7 | 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