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

Abbott Diabetes Care, Inc. · Predicate Candidate Screening

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

157 daysmedian FDA review time

292 days90th percentile

37clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K233537	FreeStyle Libre 3 Continuous Glucose Monitoring System; Free	Abbott Diabetes Care, Inc.	2024-04-23	172	2
K223435	FreeStyle Libre 3 Continuous Glucose Monitoring System; Free	Abbott Diabetes Care, Inc.	2023-04-13	150	0
K222447	FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle	Abbott Diabetes Care, Inc.	2023-03-03	200	0
K223537	FreeStyle Libre 2 System, FreeStyle Libre 3 System	Abbott Diabetes Care, Inc.	2023-02-21	90	0
K212132	FreeStyle Libre 3 Continuous Glucose Monitoring System	Abbott Diabetes Care, Inc.	2022-05-26	322	3
K213996	FreeStyle Libre 3 Continuous Glucose Monitoring System	Abbott Diabetes Care, Inc.	2022-05-26	157	1
K210943	FreeStyle Libre 2 Flash Glucose Monitoring System (with Free	Abbott Diabetes Care, Inc.	2021-11-22	237	0
K211102	FreeStyle Libre 2 Flash Glucose Monitoring System	Abbott Diabetes Care, Inc.	2021-08-11	120	0
K201761	FreeStyle Libre 2 Flash Glucose Monitoring System (with Free	Abbott Diabetes Care, Inc.	2021-07-30	396	0
K193371	FreeStyle Libre 2 Flash Glucose Monitoring System	Abbott Diabetes Care, Inc.	2020-06-12	190	2
K171941	FreeStyle Precision Neo Blood Glucose Test Strips	Abbott Diabetes Care, Inc.	2017-09-27	91	0
K153330	FreeStyle Precision Neo H Blood Glucose Monitoring System	Abbott Diabetes Care, Inc.	2016-02-19	92	0
K142928	FreeStyle Precision Neo Blood Glucose Monitoring System	Abbott Diabetes Care, Inc.	2015-09-30	356	0
K140371	FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TE	Abbott Diabetes Care, Inc.	2014-09-30	228	0
K132511	FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORIN	Abbott Diabetes Care, Inc.	2013-12-24	134	0
K120568	FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM	Abbott Diabetes Care, Inc.	2012-03-29	31	1
K092638	FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401	Abbott Diabetes Care, Inc.	2010-06-15	292	2
K092602	FREESTYLE Lite Blood Glucose Monitoring System and Freestyle	Abbott Diabetes Care, Inc.	2010-05-14	262	2
K083223	RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-	Abbott Diabetes Care, Inc.	2009-04-16	164	1
K083225	FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITOR	Abbott Diabetes Care, Inc.	2009-02-20	109	0
K081975	RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS	Abbott Diabetes Care, Inc.	2008-11-26	138	2
K080960	PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SY	Abbott Diabetes Care, Inc.	2008-09-05	155	0
K071788	AVIATOR INSULIN PUMP	Abbott Diabetes Care, Inc.	2008-01-11	193	0
K070984	THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRI	Abbott Diabetes Care, Inc.	2007-11-01	209	3
K070850	FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM	Abbott Diabetes Care, Inc.	2007-04-10	13	1
K062770	COPILOT HEALTH MANAGEMENT SYSTEM	Abbott Diabetes Care, Inc.	2006-12-14	90	0
K060768	PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KE	Abbott Diabetes Care, Inc.	2006-04-21	30	1
K051839	FREE-STYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM, MODEL 11	Abbott Diabetes Care, Inc.	2006-03-09	245	2
K051041	INSULIN PUMP	Abbott Diabetes Care, Inc.	2005-12-23	242	0
K051802	FREESTYLE CONNECT BLOOD GLUCOSE MONITORING SYSTEM	Abbott Diabetes Care, Inc.	2005-08-09	35	1
K050500	FREESTYLE 600 BLOOD GLUCOSE MONITORING SYSTEM	Abbott Diabetes Care, Inc.	2005-06-27	119	0
K031260	FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER	Abbott Diabetes Care, Inc.	2003-12-19	242	0
K020866	FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM	Abbott Diabetes Care, Inc.	2002-06-11	85	0
K012014	MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM	Abbott Diabetes Care, Inc.	2001-12-05	176	0
K000582	FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001	Abbott Diabetes Care, Inc.	2000-12-05	287	0
K994433	CONNECT DATA MANAGEMENT SYSTEM	Abbott Diabetes Care, Inc.	2000-05-05	127	1
K992684	FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM	Abbott Diabetes Care, Inc.	2000-01-14	157	2

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