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

I-Sens, Inc. — Predicate Candidate Screening

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

122 daysmedian FDA review time

357 days90th percentile

27clearances measured

K-number	Device	Applicant	Decided	Review days
K230625	ReliOn Premier BLU Blood Glucose Monitoring System	I-Sens, Inc.	2023-08-10	157
K222656	LDE4 Lancing Device	I-Sens, Inc.	2022-11-23	82
K201394	CareSens N Feliz Blood Glucose Monitoring System, CareSens N	I-Sens, Inc.	2021-10-05	496
K201551	KetoSens BT Blood B-Ketone Monitoring System	I-Sens, Inc.	2020-09-09	92
K192859	CareSens S Clear BT Blood Glucose Monitoring System	I-Sens, Inc.	2020-01-24	112
K193590	CareSens S Fit BT Blood Glucose Monitoring System	I-Sens, Inc.	2020-01-17	25
K192220	ReliOn Premier Classic Blood Glucose Monitoring System	I-Sens, Inc.	2019-12-13	120
K181273	GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUC	I-Sens, Inc.	2018-11-01	171
K180866	CareSens S Fit Blood Glucose Monitoring System	I-Sens, Inc.	2018-08-31	151
K170463	KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Bl	I-Sens, Inc.	2018-04-13	422
K171480	NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blo	I-Sens, Inc.	2017-12-13	208
K170614	CareSens N Premier Blood Glucose Monitoring System, CareSens	I-Sens, Inc.	2017-10-19	232
K160742	NoCoding1 Plus Blood Glucose Monitoring System	I-Sens, Inc.	2016-12-16	274
K151164	Assure Prism multi Blood Glucose Monitoring System	I-Sens, Inc.	2015-08-07	98
K133346	SMARTLOG DIABETES MANAGEMENT SOFTWARE	I-Sens, Inc.	2013-12-19	50
K132288	CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARE	I-Sens, Inc.	2013-11-22	122
K130696	CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM; CARESENS N	I-Sens, Inc.	2013-08-21	160
K131419	ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM	I-Sens, Inc.	2013-08-09	85
K121654	AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP	I-Sens, Inc.	2012-09-05	92
K121133	CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM	I-Sens, Inc.	2012-07-10	88
K120759	CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD	I-Sens, Inc.	2012-06-05	84
K120351	CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N PO	I-Sens, Inc.	2012-05-03	87
K103278	ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD	I-Sens, Inc.	2011-10-28	357
K103396	COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, C	I-Sens, Inc.	2011-09-27	312
K100937	PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE	I-Sens, Inc.	2010-12-21	260
K083468	CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER	I-Sens, Inc.	2009-02-10	78
K080923	CARESENS BLOOD GLUCOSE MONITORING SYSTEM; CARESENS II METER,	I-Sens, Inc.	2008-10-17	198

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