Cleared Traditional

K241810 - MICROLET®NEXT Lancet (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K241810 · Ascensia Diabetes Care U.S., Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Aug 2024
Decision
55d
Days
Class 2
Risk

K241810 is an FDA 510(k) clearance for the MICROLET®NEXT Lancet. Classified as Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature (product code QRK), Class II - Special Controls.

Submitted by Ascensia Diabetes Care U.S., Inc. (Parsippany, US). The FDA issued a Cleared decision on August 15, 2024 after a review of 55 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4850 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ascensia Diabetes Care U.S., Inc. devices

Submission Details

510(k) Number K241810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2024
Decision Date August 15, 2024
Days to Decision 55 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 114d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4850
Definition A Disposable Blood Lancet Intended For A Single Use That Is Comprised Of A Single Use Blade Attached To A Solid, Nonreusable Base That Is Used To Puncture The Skin To Obtain A Drop Of Blood For Diagnostic Purposes.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

All 14
Devices cleared under the same product code (QRK) and FDA review panel - the closest regulatory comparables to K241810.
droplet® personal lancets
K250016 · Htl-Strefa S.A · Jul 2025
Disposable Blood Lancet (Soft Pro)
K244031 · SteriLance Medical (Suzhou), Inc. · Feb 2025
Sterile Lancets for Single Use
K242622 · Ningbo Caremed Medical Products Co., Ltd. · Oct 2024
Lancing System
K232330 · Ningbo Medsun Medical Co., Ltd. · Jan 2024
SG Lanset I, SG Lancets, Soft Lancets
K230712 · Sewon Medical Co. · Dec 2023
STAT Medical Device Lancing System
K230310 · Stat Medical Devices · Sep 2023