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

Bionime Corporation — Predicate Candidate Screening

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

170 daysmedian FDA review time

307 days90th percentile

21clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K240637	RIGHTEST Blood Glucose Monitoring System Max Tel	Bionime Corporation	2024-11-04	243	0
K231192	RIGHTEST Blood Glucose Monitoring System Max Tel	Bionime Corporation	2024-01-19	267	0
K221062	RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose L	Bionime Corporation	2022-09-26	168	0
K190564	Rightest Blood Glucose Monitoring System GM700S, Rightest Bl	Bionime Corporation	2019-06-02	89	0
K173638	Rightest Blood Glucose Monitoring System Max, Rightest Blood	Bionime Corporation	2018-08-17	266	0
K173139	Rightest Blood Glucose Monitoring System Wiz, Rightest Blood	Bionime Corporation	2018-06-19	263	0
K170143	GE Blood Glucose Monitoring System 180, GE Blood Glucose Mon	Bionime Corporation	2017-07-06	170	0
K161790	iGlucose Blood Glucose Monitoring System	Bionime Corporation	2017-05-02	307	0
K140210	RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST P	Bionime Corporation	2014-08-22	206	0
K133003	RIGHTEST CONTROL SOLUTION	Bionime Corporation	2013-10-24	29	0
K123008	RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOO	Bionime Corporation	2013-01-25	120	0
K120423	BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM65	Bionime Corporation	2012-08-03	172	0
K110737	RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700	Bionime Corporation	2012-03-29	379	0
K113007	BIONIME DIABETES MANAGEMENT SYSTEM VI.0	Bionime Corporation	2012-02-27	143	0
K092052	RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM550	Bionime Corporation	2010-06-18	346	0
K081451	RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM100	Bionime Corporation	2008-09-18	118	0
K081450	RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM110	Bionime Corporation	2008-09-11	111	0
K072054	RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM310	Bionime Corporation	2008-02-28	217	0
K062567	RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM	Bionime Corporation	2007-02-16	169	1
K053635	MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM	Bionime Corporation	2006-02-21	54	1
K042678	RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM	Bionime Corporation	2005-01-03	96	1

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