Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Soflex Limited · 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) |
|---|---|---|---|---|---|
| K122220 | ENI-EYE SH SOFT K SEMI SCLERAL (EFROFILCON A) SOFT (HYDROPHI | Soflex Limited | 2013-03-19 | 237 | 0 |
| K122213 | ENI-EYE SH SPHERE (EFROFILCON A) SOFT (HYDROPHILIC) CONTACT | Soflex Limited | 2012-12-12 | 140 | 0 |
| K110261 | ENI-EYE SH TORIC (EFROFILCON A) SOFT HYDROPHILIC TORIC CONTA | Soflex Limited | 2011-07-28 | 181 | 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