Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Staar Surgical Co. — Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
138 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K090161 | EPIPHANY INJECTION SYSTEM | Staar Surgical Co. | 2009-06-09 | 138 | 0 |
| K073591 | MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM | Staar Surgical Co. | 2008-03-13 | 84 | 0 |
| K073586 | MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM | Staar Surgical Co. | 2008-03-13 | 84 | 0 |
| K032412 | RE-USEABLE MICROSTAAR INJECTOR, MSI-S | Staar Surgical Co. | 2004-06-10 | 310 | 0 |
| K020734 | SURGE-FREE ASPIRATION ADAPTER | Staar Surgical Co. | 2002-05-16 | 71 | 0 |
| K983129 | DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1) | Staar Surgical Co. | 1998-12-04 | 87 | 0 |
| K980696 | FOAM TIP INJECTOR | Staar Surgical Co. | 1998-09-11 | 200 | 1 |
| K954600 | MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION) | Staar Surgical Co. | 1995-12-21 | 87 | 0 |
| K913626 | SOFTRANS INJECTOR | Staar Surgical Co. | 1991-12-18 | 125 | 0 |
| K884241 | STAAR PHACO XL SMALL INCISION SYSTEM | Staar Surgical Co. | 1989-02-17 | 129 | 0 |
| K875099 | MOLTENO VALVE SETON | Staar Surgical Co. | 1988-03-30 | 111 | 0 |
| K864071 | FAULKNER FORCEPS | Staar Surgical Co. | 1986-11-13 | 24 | 0 |
| K861990 | SOFT LENS FOLDER | Staar Surgical Co. | 1986-06-17 | 25 | 0 |
| K861085 | ELASTIC LENS INJECTOR TM | Staar Surgical Co. | 1986-05-28 | 68 | 0 |
| K860544 | BACSTOP FILTER IRRIGATION SUPPLY KIT | Staar Surgical Co. | 1986-04-04 | 50 | 0 |
| K860148 | MAZZOCCO/FRENCHIK FOLDER | Staar Surgical Co. | 1986-03-21 | 65 | 0 |
| K851936 | STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT | Staar Surgical Co. | 1985-08-20 | 106 | 0 |
| K852208 | PHACO-BAC STOP FILTER KIT | Staar Surgical Co. | 1985-08-20 | 91 | 0 |
| K850900 | PHACO-BAC STOP KIT | Staar Surgical Co. | 1985-03-29 | 25 | 0 |
| K850899 | I/A BAC STOP KIT | Staar Surgical Co. | 1985-03-29 | 25 | 0 |
| K831172 | ULTRAKIT | Staar Surgical Co. | 1983-06-08 | 58 | 0 |
| K831159 | I/A KIT | Staar Surgical Co. | 1983-04-28 | 17 | 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