Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Largan Medical Co., Ltd. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
133 daysmedian FDA review time
269 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242916 | Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) C | Largan Medical Co., Ltd. | 2025-02-04 | 133 | 0 |
| K233501 | “LARGAN Health AI-Tech” Sleep Apnea and Sleep Quality Examin | Largan Medical Co., Ltd. | 2024-07-26 | 269 | 0 |
| K202129 | Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophi | Largan Medical Co., Ltd. | 2021-04-01 | 244 | 0 |
| K182674 | Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact | Largan Medical Co., Ltd. | 2018-11-13 | 48 | 0 |
| K182523 | Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophili | Largan Medical Co., Ltd. | 2018-11-01 | 49 | 0 |
| K181232 | Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Con | Largan Medical Co., Ltd. | 2018-06-29 | 51 | 0 |
| K181230 | Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Cont | Largan Medical Co., Ltd. | 2018-06-25 | 47 | 0 |
| K170286 | Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact | Largan Medical Co., Ltd. | 2017-09-18 | 231 | 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