Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Truly Instrument Limited — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
147 daysmedian FDA review time
382 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220276 | Infrared Thermometer TET-351 | Truly Instrument Limited | 2023-02-17 | 382 | 0 |
| K192023 | Arm Blood Pressure Monitor | Truly Instrument Limited | 2019-12-23 | 147 | 0 |
| K161846 | Automatic Arm Bluetooth Blood Pressure Monitor | Truly Instrument Limited | 2016-10-24 | 111 | 0 |
| K090564 | TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET- | Truly Instrument Limited | 2009-06-24 | 114 | 0 |
| K081852 | TRULY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL DB11 | Truly Instrument Limited | 2008-12-12 | 165 | 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