Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
First Source, Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240009 | iQFlex Pro | First Source, Inc. | 2024-07-03 | 183 | 0 |
| K221081 | iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System | First Source, Inc. | 2022-06-13 | 62 | 1 |
| K203703 | I-Q View | First Source, Inc. | 2021-03-24 | 96 | 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