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

NFT — Predicate Candidate Screening

31 FDA 510(k) clearances under this product code; the 50 most recent screened below.

40 daysmedian FDA review time

109 days90th percentile

31clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K261984	AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test	Assure Tech., LLC	2026-07-17	35	0
K261280	BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Uri	Vivachek Biotech (Hangzhou) Co., Ltd.	2026-05-22	35	0
K260065	SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip M	Guangzhou Wondfo Biotech Co., Ltd.	2026-04-28	109	0
K260355	Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cu	WEBEST Biotech,, LLC	2026-03-09	34	0
K252550	SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Mul	Guangzhou Wondfo Biotech Co., Ltd.	2025-11-18	97	0
K252867	VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Tes	Advin Biotech, Inc.	2025-10-09	30	0
K252554	Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine	Vivachek Biotech (Hangzhou) Co., Ltd.	2025-09-12	30	0
K252118	CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home	Hangzhou Clongene Biotech Co., Ltd.	2025-08-27	51	0
K252259	AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test	Assure Tech., LLC	2025-08-15	25	0
K250727	AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug	Hangzhou AllTest Biotech Co., Ltd.	2025-04-04	24	0
K244043	AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test	Hangzhou AllTest Biotech Co., Ltd.	2025-02-27	59	0
K243996	AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; Assu	Assure Tech., LLC	2025-02-07	43	0
K242498	Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Pan	Aicheck Biotech, Inc.	2024-10-01	40	0
K242540	AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapi	Hangzhou AllTest Biotech Co., Ltd.	2024-09-27	32	0
K242077	PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Te	Aicheck Biotech, Inc.	2024-08-14	29	0
K241428	AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid	Hangzhou AllTest Biotech Co., Ltd.	2024-06-17	28	0
K233062	BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Dru	Vivachek Biotech (Hangzhou) Co., Ltd.	2023-11-02	37	0
K222667	Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine	Vivachek Biotech (Hangzhou) Co., Ltd.	2022-11-10	65	0
K221871	Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healst	Healstone Biotech, Inc.	2022-08-30	63	0
K220685	HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine	Qingdao Hightop Biotech Co., Ltd.	2022-05-05	58	0
K202453	SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urin	Safecare Biotech (Hangzhou) Co., Ltd.	2021-03-24	209	0
K202567	Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi	Guangzhou Wondfo Biotech Co., Ltd.	2020-09-25	21	0
K201120	SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urin	Safecare Biotech (Hangzhou) Co., Ltd.	2020-05-27	30	0
K191841	Accurate Multi Panel Drug Urine Test Cup	Healstone Biotech, Inc.	2019-08-07	29	0
K182701	Wondfo T-Cup Multi-Drug Urine Test Cup	Guangzhou Wondfo Biotech Co., Ltd.	2018-12-03	67	1
K182530	BIOEASY Multi-Drug Test Cup	Shenzhen Bioeasy Biotechnology Co., Ltd.	2018-11-09	56	0
K181768	AssureTech Panel Dip Tests, AssureTech Quick Cup Tests	Assure Tech. (Hangzhou) Co, Ltd.	2018-08-20	48	0
K181968	SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urin	Safecare Biotech (Hangzhou) Co., Ltd.	2018-08-20	27	0
K180349	AssureTech Panel Dip Tests, AssureTech Quick Cup Tests	Assure Tech. (Hangzhou) Co, Ltd.	2018-04-05	56	0
K171695	First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug C	W.H.P.M., Inc.	2018-02-05	243	0
K170049	AssureTech Panel Dip Test, AssureTech Quick Cup Test	Assure Tech. (Hangzhou) Co, Ltd.	2017-05-02	117	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