Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Quanta Computer, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
214 daysmedian FDA review time
557 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231855 | QOCA® image Smart RT Contouring System | Quanta Computer, Inc. | 2024-02-13 | 235 | 0 |
| K221868 | QOCA image Smart CXR Image Processing System | Quanta Computer, Inc. | 2023-01-27 | 214 | 0 |
| K210179 | QOCA Portable ECG Monitoring Device | Quanta Computer, Inc. | 2022-08-02 | 557 | 0 |
| K083079 | QUANTA PULSE OXIMETER, MODEL: PULSE LINK 1000 OR QH100 | Quanta Computer, Inc. | 2009-03-05 | 140 | 0 |
| K083078 | QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH | Quanta Computer, Inc. | 2008-11-26 | 41 | 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