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FDA 510(k)

MICROLET®NEXT 2 Lancing Device

K-Number: K250813 · 2025-05-14

ApplicantAscensia Diabetes Care U.S., Inc.
Decision Date2025-05-14
Product CodeQRL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MICROLET®NEXT 2 Lancing Device is a medical device manufactured by Ascensia Diabetes Care U.S., Inc.. It received FDA 510(k) clearance on 2025-05-14 under approval number K250813. The device is classified under product code QRL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROLET®NEXT 2 Lancing Device?

MICROLET®NEXT 2 Lancing Device is a medical device that received FDA 510(k) clearance on 2025-05-14. It is manufactured by Ascensia Diabetes Care U.S., Inc.. The 510(k) number is K250813.

When was MICROLET®NEXT 2 Lancing Device approved by the FDA?

MICROLET®NEXT 2 Lancing Device received FDA 510(k) clearance on 2025-05-14, under approval number K250813.

What company makes MICROLET®NEXT 2 Lancing Device?

MICROLET®NEXT 2 Lancing Device is manufactured by Ascensia Diabetes Care U.S., Inc..

What is the FDA product code for MICROLET®NEXT 2 Lancing Device?

The FDA product code for MICROLET®NEXT 2 Lancing Device is QRL.

Other Devices by Ascensia Diabetes Care U.S., Inc.

K160430Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System K162336Contour Next EZ Blood Glucose Monitoring System K223293CONTOUR® NEXT GEN Blood Glucose Monitoring System K220633MICROLET NEXT lancing device, MICROLET Lancet K241787CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System K241810MICROLET®NEXT Lancet

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Related Devices (Code: QRL)

K222472Lancing System, Sterile Lancet for Single Use, Lancing DeviceShandong Lianfa Medical Plastic Products Co. , Ltd. K223099Facet Manatee Reusable Lancing BaseFacet Technologies, LLC K222656LDE4 Lancing DeviceI-Sens, Inc. K222246Disposable Sterile LancetTianjin Rilifine Medical Device Co., Ltd. K222539Facet Blood LancetsFacet Technologies, LLC K221072TRUEdraw Lancing Device, Mini Lancing DeviceTrividia Health

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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