Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QT Medical, Inc. · 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) |
|---|---|---|---|---|---|
| K233521 | QT ECG (QTERD100) | QT Medical, Inc. | 2023-12-06 | 35 | 0 |
| K220795 | QT ECG | QT Medical, Inc. | 2022-09-26 | 192 | 0 |
| K200722 | PCA-C1 series Patient Cable | QT Medical, Inc. | 2021-06-03 | 441 | 0 |
| K180157 | QT ECG | QT Medical, Inc. | 2018-05-04 | 105 | 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