Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Qisda Corporation — 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) |
|---|---|---|---|---|---|
| K192254 | InnoSight Diagnostic Ultrasound System | Qisda Corporation | 2019-09-18 | 29 | 0 |
| K181313 | BenQ Diagnostic Ultrasound System | Qisda Corporation | 2018-08-27 | 102 | 0 |
| K172056 | InnoSight Diagnostic Ultrasound System | Qisda Corporation | 2017-12-13 | 160 | 0 |
| K132690 | UP600 DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM | Qisda Corporation | 2014-02-25 | 181 | 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