Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Truly Instrument Co., Ltd. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K113083 | TRULY AUTOMATIC ARM BLOOD PRESSURE MONITOR | Truly Instrument Co., Ltd. | 2012-01-19 | 93 | 0 |
| K113085 | TRYLY AUTOMATIC WRIST BLOOD PRESSURE MONITOR | Truly Instrument Co., Ltd. | 2012-01-12 | 86 | 0 |
| K091415 | TRULY AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODEL DW100,DW | Truly Instrument Co., Ltd. | 2009-09-04 | 114 | 0 |
| K091434 | TRULY AUTOMATIC ARM BLOOD PRESSURE MONITORDB21,DB31,DB22,DB2 | Truly Instrument Co., Ltd. | 2009-09-04 | 114 | 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