Data / Medical devices / United States / Ascensia Diabetes Care US Inc.

Ascensia Diabetes Care US Inc.: FDA-registered device maker in Valhalla, NY, United States, 24 510(k) clearances and 2 PMA approvals

Name: Ascensia Diabetes Care US Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Ascensia Diabetes Care US Inc. is registered with the FDA (registration 1810909) in Valhalla, NY, United States. It lists 10 device types. The FDA files 24 510(k) clearances and 2 PMA approvals under its listings, the newest dated August 27, 2026. 3 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 1810909
Address: 100 Summit Lake Drive, Valhalla, NY, United States, 10595
Owner or operator: Ascensia Diabetes Care Holdings AG (10050965)
Roles: Complaint file establishment, Specification developer
First device listed: January 21, 2016
Registered through: 2027
Brand names listed: CONTOUR NEXT, CONTOUR NEXT EZ, CONTOUR NEXT LINK, CONTOUR NEXT LINK 2.4, CONTOUR NEXT ONE, CONTOUR PLUS, CONTOUR PLUS LINK, CONTOUR PLUS LINK 2.4 and more

Devices it lists

Device	Product code	Class	Role	Source
Automated Insulin Dosing , Threshold Suspend	OZO	3	Complaint file establishment, Specification developer	accessdata.fda.gov
Automated Insulin Dosing Device System, Single Hormonal Control	OZP	3	Complaint file establishment, Specification developer	accessdata.fda.gov
Calculator/Data Processing Module, For Clinical Use	JQP	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Glucose Dehydrogenase, Glucose	LFR	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	JIL	2	Complaint file establishment	accessdata.fda.gov
Multiple Use Blood Lancet For Single Patient Use Only	QRL	2	Specification developer	accessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)	JIN	1	Complaint file establishment	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	QRK	2	Specification developer	accessdata.fda.gov
System, Test, Blood Glucose, Over The Counter	NBW	2	Complaint file establishment, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 27, 2026	K260545	CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring System	NBW	Substantially Equivalent	Ascensia Diabetes Care	accessdata.fda.gov
August 27, 2024	K241787	CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System	NBW	Substantially Equivalent	Ascensia Diabetes Care U.S., Inc.	accessdata.fda.gov
August 15, 2024	K241810	MICROLET®NEXT Lancet	QRK	Substantially Equivalent	Ascensia Diabetes Care U.S., Inc.	accessdata.fda.gov
February 23, 2024	K231679	CONTOUR® PLUS BLUE Blood Glucose Monitoring System	NBW	Substantially Equivalent	Ascensia Diabetes Care	accessdata.fda.gov
November 18, 2022	K223293	CONTOUR® NEXT GEN Blood Glucose Monitoring System	NBW	Substantially Equivalent	Ascensia Diabetes Care U.S., Inc.	accessdata.fda.gov
June 3, 2022	K220633	MICROLET NEXT lancing device, MICROLET Lancet	QRL	Substantially Equivalent	Ascensia Diabetes Care U.S., Inc.	accessdata.fda.gov
December 23, 2021	K193407	Contour® next GEN Blood Glucose Monitoring System	NBW	Substantially Equivalent	Ascensia Diabetes Care	accessdata.fda.gov
August 11, 2021	K210687	CONTOUR® NEXT ONE Blood Glucose Monitoring System	NBW	Substantially Equivalent	Ascensia Diabetes Care	accessdata.fda.gov
November 8, 2019	K191286	CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System	NBW	Substantially Equivalent	Ascensia Diabetes Care	accessdata.fda.gov
January 12, 2017	K162336	Contour Next EZ Blood Glucose Monitoring System	NBW	Substantially Equivalent	Ascensia Diabetes Care U.S., Inc.	accessdata.fda.gov
November 17, 2016	K160682	CONTOUR NEXT ONE Blood Glucose Monitoring System	NBW	Substantially Equivalent	Ascensia Diabetes Care	accessdata.fda.gov
June 24, 2016	K160430	Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System	NBW	Substantially Equivalent	Ascensia Diabetes Care U.S., Inc.	accessdata.fda.gov
September 23, 2015	K151742	Contour Next Control Solution	JJX	Substantially Equivalent	Bayer Healthcare	accessdata.fda.gov
June 23, 2014	K130265	CONTOUR NEXT EZ BLOOD GLUCOSE METER	NBW	Substantially Equivalent	Bayer Healthcare, LLC	accessdata.fda.gov
September 26, 2013	K122370	CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR	NBW	Substantially Equivalent	Bayer Healthcare	accessdata.fda.gov
July 26, 2012	K121190	CONTOUR NEXT BLOOD GLUCOSE METER	LFR	Substantially Equivalent	Bayer Healthcare, LLC	accessdata.fda.gov
June 28, 2012	K121087	CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM	NBW	Substantially Equivalent	Bayer Healthcare	accessdata.fda.gov
March 28, 2012	K110894	CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER	LFR	Substantially Equivalent	Bayer Healthcare	accessdata.fda.gov
March 6, 2012	K111268	CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM	LFR	Substantially Equivalent	Bayer Healthcare	accessdata.fda.gov
December 4, 2009	K090628	DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080	NBW	Substantially Equivalent	Bayer Healthcare, LLC	accessdata.fda.gov
August 26, 2009	K091820	CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM	NBW	Substantially Equivalent	Bayer Healthcare	accessdata.fda.gov
September 11, 2006	K062058	ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080	NBW	Substantially Equivalent	Bayer Healthcare	accessdata.fda.gov
September 8, 1983	K831600	DIASTIX REAGENT STRIPS FOR URINALYSIS	JIL	Substantially Equivalent	Miles Laboratories, Inc.	accessdata.fda.gov
July 8, 1980	K801270	TEST FOR KETONE IN URINE(ACETOACETIC AC	JIN	Substantially Equivalent	Miles Laboratories, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
September 28, 2016	P160017	MiniMed 670G System	OZP	126	September 29, 2026	accessdata.fda.gov
August 10, 2016	P150001	MINIMED 630G SYSTEM WITH SMARTGUARD(TM)	OZO	100	July 21, 2026	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
May 19, 2023	92536	Class II	Ongoing	Contour next GEN Blood Glucose Monitoring System	Ascensia Diabetes Care has determined through customer complaints that 580 of 2900 meters from lot number DM01T033P are reconfigured from mg/dL to mmol/L. Among them, 579 meters distributed in the United States were packaged into the meter kit and had incorrect factory-set unit of measure where the meters display glucose results in mmol/L rather than mg/dL.	accessdata.fda.gov
March 12, 2004	29444	Not yet classified	Terminated	Clinitek 50 Urine Chemistry Analyzer; Product codes 6509C, 6513K, 6514C, 6515C, 6516F and 6518C. [The different product codes are for the various countries where the product is distributed).	Some units may only have had 1 read head screw installed instead of the three required by the firm's specifications.	accessdata.fda.gov
June 19, 2003	26312	Not yet classified	Terminated	Clinitek 50 Urine Chemistry Analyzer; Product codes 6509C, 6513K, 6514C, 6515C, 6516F and 6518C. [The different product codes are for the various countries where the product is distributed.]	Analyzer will produce erroneous results due to missing grounding strap.	accessdata.fda.gov

Compare with other makers

Updated September 29, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.