Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sauflon Pharmaceuticals, Ltd. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
165 daysmedian FDA review time
221 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K133740 | SAUFLON CLARITI WITH TINT, SAUFLON CLARITI TORIC WITH TINT, | Sauflon Pharmaceuticals, Ltd. | 2014-03-05 | 86 | 0 |
| K130342 | SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LE | Sauflon Pharmaceuticals, Ltd. | 2013-08-05 | 175 | 0 |
| K130331 | SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAIL | Sauflon Pharmaceuticals, Ltd. | 2013-07-26 | 165 | 0 |
| K130734 | SAUFLON MULTIPURPOSE SOLUTION | Sauflon Pharmaceuticals, Ltd. | 2013-05-15 | 58 | 0 |
| K052832 | SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DIS | Sauflon Pharmaceuticals, Ltd. | 2006-05-15 | 221 | 0 |
| K052809 | SAUFLON FLAT COLOURED LENS CASE | Sauflon Pharmaceuticals, Ltd. | 2005-11-02 | 29 | 0 |
| K033656 | SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE | Sauflon Pharmaceuticals, Ltd. | 2004-02-02 | 73 | 0 |
| K030278 | SAUFLON MULTIPURPOSE SOLUTION - NO RUB | Sauflon Pharmaceuticals, Ltd. | 2003-07-30 | 184 | 0 |
| K013649 | SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS | Sauflon Pharmaceuticals, Ltd. | 2001-12-26 | 51 | 0 |
| K010559 | SAUFLON MULTI LENS CARE SYSTEM | Sauflon Pharmaceuticals, Ltd. | 2001-12-20 | 297 | 1 |
| K011456 | DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONT | Sauflon Pharmaceuticals, Ltd. | 2001-07-17 | 67 | 0 |
| K991125 | SAUFLON AEROTAB DISINFECTING SYSTEM FOR THE DISINFECTION OF | Sauflon Pharmaceuticals, Ltd. | 1999-09-14 | 165 | 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