Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Suntech Medical Instruments, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
317 daysmedian FDA review time
347 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K010622 | PRESSURE TRAK, MODEL 222-B | Suntech Medical Instruments, Inc. | 2001-03-29 | 27 | 0 |
| K003004 | OSCAR 2, MODEL 222 | Suntech Medical Instruments, Inc. | 2000-10-25 | 30 | 0 |
| K970629 | TANGO NON-INVASIVE BLOOD PRESSURE MONITOR | Suntech Medical Instruments, Inc. | 1998-01-02 | 317 | 0 |
| K914260 | 4240 DYNAMIC BP/HEART RATE MONITOR | Suntech Medical Instruments, Inc. | 1992-09-04 | 347 | 0 |
| K913844 | ACCUTRACKER DX | Suntech Medical Instruments, Inc. | 1992-07-14 | 321 | 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