Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gelflex Laboratories · 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) |
|---|---|---|---|---|---|
| K181558 | Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, So | Gelflex Laboratories | 2018-09-06 | 85 | 0 |
| K030027 | GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR | Gelflex Laboratories | 2003-04-01 | 88 | 0 |
| K962710 | GELFLEX DELTA 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS | Gelflex Laboratories | 1996-09-05 | 87 | 0 |
| K962711 | GELFLEX ALPHA (POLYMACON) HYDROPHILIC CONTACT LENS | Gelflex Laboratories | 1996-09-05 | 87 | 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