Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Yung Sheng Optical Co., Ltd. · Predicate Candidate Screening

10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

102 daysmedian FDA review time
459 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K244009Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilYung Sheng Optical Co., Ltd.2025-09-252730
K232839Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV AsYung Sheng Optical Co., Ltd.2024-12-164590
K223585Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilYung Sheng Optical Co., Ltd.2023-12-203840
K213983Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) CYung Sheng Optical Co., Ltd.2022-09-022560
K151586Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic)Yung Sheng Optical Co., Ltd.2015-08-10600
K150630Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) ConYung Sheng Optical Co., Ltd.2015-06-15960
K143190Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophiliYung Sheng Optical Co., Ltd.2015-01-16720
K143052Eye Secret 38 UV Aspheric Color(polymacon) Soft(hydrophilic)Yung Sheng Optical Co., Ltd.2014-12-16540
K133735EYE SECRET 55 UV ASPHERIC (METHAFILCON A) SOFT (HYDROPHILIC)Yung Sheng Optical Co., Ltd.2014-03-211020
K132854EYE SECRET 38 UV ASPHERIC (POLYMACON) SOFT (HYDROPHILIC) CONYung Sheng Optical Co., Ltd.2013-12-231020

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