Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rayner Surgical, 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) |
|---|---|---|---|---|---|
| K081455 | RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL | Rayner Surgical, Inc. | 2008-09-05 | 105 | 0 |
| K062612 | RAYNER SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, MODEL R-I | Rayner Surgical, Inc. | 2006-12-13 | 99 | 0 |
| K052651 | C-FLEX SYSTEM SINGLE USE DISPOSABLE INJECTOR, MODEL R-INJ-02 | Rayner Surgical, Inc. | 2006-01-19 | 115 | 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