Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Shenzhen Nuon Medical Equipment Co., Ltd. · Predicate Candidate Screening

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

179 daysmedian FDA review time
259 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K251034Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); RadianShenzhen Nuon Medical Equipment Co., Ltd.2025-10-121920
K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, Shenzhen Nuon Medical Equipment Co., Ltd.2025-04-082590
K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59DShenzhen Nuon Medical Equipment Co., Ltd.2024-12-191010
K241342Hair Growth Comb (SZ-23,SZ-23A)Shenzhen Nuon Medical Equipment Co., Ltd.2024-11-081790
K241155Cold Sore Device (QPZ-03)Shenzhen Nuon Medical Equipment Co., Ltd.2024-09-051330

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