Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vizionfocus, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
111 daysmedian FDA review time
125 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251573 | VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophil | Vizionfocus, Inc. | 2025-09-10 | 111 | 0 |
| K243953 | Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact L | Vizionfocus, Inc. | 2025-04-10 | 108 | 0 |
| K242413 | VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophil | Vizionfocus, Inc. | 2024-12-17 | 125 | 0 |
| K192225 | Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) | Vizionfocus, Inc. | 2019-12-09 | 115 | 0 |
| K182247 | ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact L | Vizionfocus, Inc. | 2018-10-12 | 53 | 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