Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rayner Intraocular Lenses , Ltd. · 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) |
|---|---|---|---|---|---|
| K143307 | RaySert PLUS Injector, Single Use Soft Tipped Disposable Inj | Rayner Intraocular Lenses , Ltd. | 2014-12-18 | 30 | 0 |
| K141091 | RAYSERT PLUS INJECTOR | Rayner Intraocular Lenses , Ltd. | 2014-05-28 | 30 | 0 |
| K132002 | SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE U | Rayner Intraocular Lenses , Ltd. | 2014-03-27 | 269 | 0 |
| K091507 | RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL | Rayner Intraocular Lenses , Ltd. | 2009-12-04 | 197 | 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