Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
First Ray, LLC — 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) |
|---|---|---|---|---|---|
| K163440 | Stealth Staple System | First Ray, LLC | 2017-02-01 | 55 | 0 |
| K153585 | Flip Button Suture Anchor | First Ray, LLC | 2016-05-05 | 141 | 0 |
| K153638 | Bicortical Fixation Screw & Washer Nut System | First Ray, LLC | 2016-04-19 | 123 | 0 |
| K153622 | First Ray Internal Bone Staple System | First Ray, LLC | 2016-04-08 | 112 | 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