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

NBW · Predicate Candidate Screening

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

153 daysmedian FDA review time

429 days90th percentile

509clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K262116	TRUE METRIX Self Monitoring Blood Glucose System	Trividia Health, Inc.	2026-07-23	30	0
K250085	On Call® Sure GK Blood Glucose & Ketone Monitoring System; O	ACON Laboratories, Inc.	2025-10-10	270	0
K243060	TeleRPM Gen2 Blood Glucose Monitoring System	Guangdong Transtek Medical Electronics Co., Ltd.	2025-01-30	125	0
K240637	RIGHTEST Blood Glucose Monitoring System Max Tel	Bionime Corporation	2024-11-04	243	0
K240640	Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Bl	Sejoy Biomedical Co., Ltd.	2024-10-08	216	0
K241787	CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR®	Ascensia Diabetes Care U.S., Inc.	2024-08-27	67	0
K222126	VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad	Vivachek Biotech (Hangzhou) Co., Ltd.	2024-08-16	760	0
K241304	WaveSense Jazz Blood Glucose Monitoring System	Agamatrix	2024-06-06	28	0
K231679	CONTOUR® PLUS BLUE Blood Glucose Monitoring System	Ascensia Diabetes Care	2024-02-23	259	0
K231192	RIGHTEST Blood Glucose Monitoring System Max Tel	Bionime Corporation	2024-01-19	267	0
K233058	VivaChek Link Plus Blood Glucose Monitoring System	Vivachek Biotech (Hangzhou) Co., Ltd.	2023-12-22	88	0
K231476	TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blo	Sinocare, Inc.	2023-12-01	193	0
K213131	Accu-Chek Guide Solo diabetes manager blood glucose monitori	Roche Diabetes Care GmbH	2023-08-10	682	0
K230625	ReliOn Premier BLU Blood Glucose Monitoring System	I-Sens, Inc.	2023-08-10	157	0
K223722	MIO Blood Glucose Monitoring System	Mio Labs, Inc.	2023-06-28	198	0
K222234	GlucoSure ADVANCE Link Blood Glucose Monitoring System	Apex BioTechnology Corp.	2022-12-21	148	0
K223293	CONTOUR® NEXT GEN Blood Glucose Monitoring System	Ascensia Diabetes Care U.S., Inc.	2022-11-18	23	0
K220421	BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Gl	Apex BioTechnology Corp.	2022-11-04	263	0
K213061	SuperCheck Pro Blood Glucose Monitoring System	Ok Biotech Co., Ltd.	2022-10-07	380	0
K212248	GlucoLeader Enhance 2 Blood Glucose Monitoring System	Hmd Biomedical, Inc.	2022-08-29	406	0
K212140	GlucoSure Link Blood Glucose Monitoring System	Apex BioTechnology Corp.	2022-08-25	413	0
K202739	Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-	Bioland Technology, Ltd.	2022-08-12	693	0
K201037	FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitor	Taidoc Technology Corporation	2022-06-16	787	0
K203711	IWL2020 Blood Glucose Monitoring System	Roche Diabetes Care, Inc.	2022-05-06	501	0
K202534	MTM301 Blood Glucose and Ketone Monitoring System	Apex BioTechnology Corp.	2022-04-06	582	0
K213887	GAL-1A Plus Blood Glucose Monitoring System	Apex BioTechnology Corp.	2022-03-29	106	0
K193406	CardioChek Plus Test System; CardioChek Plus Home Test Syste	Polymer Technology Systems, Inc. D/B/A Pts Diagnostics	2022-02-26	810	0
K193407	Contour® next GEN Blood Glucose Monitoring System	Ascensia Diabetes Care	2021-12-23	745	1
K201880	MultiSure GK Link Blood Glucose and Ketone Monitoring System	Apex BioTechnology Corp.	2021-10-15	465	0
K201394	CareSens N Feliz Blood Glucose Monitoring System, CareSens N	I-Sens, Inc.	2021-10-05	496	0
K202885	GlucoSure HT Plus Blood Glucose Monitoring System	Apex BioTechnology Corp.	2021-09-15	352	0
K201258	EASYMAX Tag Self-Monitoring Blood Glucose System	Eps Bio Technology Corp.	2021-09-01	478	0
K210687	CONTOUR® NEXT ONE Blood Glucose Monitoring System	Ascensia Diabetes Care	2021-08-11	156	0
K203562	Finetest Lite Blood Glucose Monitoring System	Osang Healthcare Co. , Ltd.	2021-07-13	218	0
K201396	Finetest Lite Smart Blood Glucose Monitoring System	Osang Healthcare Co. , Ltd.	2020-10-16	141	0
K193340	GoChek Blood Glucose Monitoring System, GoChek Connect Blood	Microtech Medical, Inc.	2020-09-11	284	0
K200277	Livongo Blood Glucose Monitoring System (BG1000)	Livongo Health, Inc.	2020-06-04	121	0
K191657	Bioland Blood Glucose Monitoring System	Bioland Technology, Ltd.	2020-03-20	273	0
K193475	OneTouch Verio Reflect Blood Glucose Monitoring System	Lifescan Europe GmbH	2020-02-14	60	0
K192859	CareSens S Clear BT Blood Glucose Monitoring System	I-Sens, Inc.	2020-01-24	112	0
K193590	CareSens S Fit BT Blood Glucose Monitoring System	I-Sens, Inc.	2020-01-17	25	0
K192220	ReliOn Premier Classic Blood Glucose Monitoring System	I-Sens, Inc.	2019-12-13	120	0
K191286	CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT	Ascensia Diabetes Care	2019-11-08	179	0
K190189	MDT2 BLE Self-Monitoring Blood Glucose System	Eps Bio Technology Corp.	2019-11-01	273	0
K192175	On Call Express II Blood Glucose Monitoring System	ACON Laboratories, Inc.	2019-10-17	66	0
K191038	On Call Express Voice Blood Glucose Monitoring System	ACON Laboratories, Inc.	2019-06-12	55	0
K190579	TD-4183 Blood Glucose Monitoring System	Taidoc Technology Corporation	2019-06-04	90	0
K190564	Rightest Blood Glucose Monitoring System GM700S, Rightest Bl	Bionime Corporation	2019-06-02	89	0
K182428	GlucoLeader Enhance Blood Glucose Monitoring System	Hmd Biomedical, Inc.	2019-05-08	244	0
K183306	GLUCOCARD® W onyx Blood Glucose Monitoring System	Arkray Factory, Inc.	2019-04-10	133	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