Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Qfix — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
95 daysmedian FDA review time
178 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230312 | Iris AirShuttle™ | Qfix | 2023-03-31 | 56 | 0 |
| K193243 | Alta Multipurpose Device | Qfix | 2020-02-28 | 95 | 0 |
| K190668 | Encompass 15 Channel Head Coil, 3T | Qfix | 2019-09-09 | 178 | 0 |
| K182189 | Encompass SRS Headframe ; Encompass MR SRS Headframe | Qfix | 2018-10-04 | 52 | 0 |
| K171133 | Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT So | Qfix | 2017-07-11 | 85 | 0 |
| K160627 | Symphony Patient Transport System, Symphony Patient Trolley, | Qfix | 2016-06-14 | 99 | 0 |
| K152321 | kVue Encompass SRS Insert (Encompass Insert), Encompass SRS | Qfix | 2015-12-04 | 109 | 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