Atlas FDA

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

Safecare Biotech (Hangzhou) Co., Ltd. · Predicate Candidate Screening

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

55 daysmedian FDA review time
209 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K242767Safecare Urinary Tract Infection TestSafecare Biotech (Hangzhou) Co., Ltd.2025-01-101190
K240654SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine TeSafecare Biotech (Hangzhou) Co., Ltd.2024-04-10340
K202453SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug UrinSafecare Biotech (Hangzhou) Co., Ltd.2021-03-242090
K200133hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine TesSafecare Biotech (Hangzhou) Co., Ltd.2020-08-132050
K201120SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug UrinSafecare Biotech (Hangzhou) Co., Ltd.2020-05-27300
K191924SAFECARE® THC Urine Strip TestSafecare Biotech (Hangzhou) Co., Ltd.2019-08-16290
K182654SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug UrinSafecare Biotech (Hangzhou) Co., Ltd.2018-11-19550
K181968SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug UrinSafecare Biotech (Hangzhou) Co., Ltd.2018-08-20270
K153646SAFECARE Urine Test Amphetamine, SAFECARE Urine Test CocaineSafecare Biotech (Hangzhou) Co., Ltd.2016-03-18880

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