Cleared Special

Disposable Blood Lancet (Soft) (K261634) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K261634 · SteriLance Medical (Suzhou), Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
25d
Days
Class 2
Risk

K261634 is an FDA 510(k) clearance for the Disposable Blood Lancet (Soft). Classified as Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature (product code QRK), Class II - Special Controls.

Submitted by SteriLance Medical (Suzhou), Inc. (Suzhou, CN). The FDA issued a Cleared decision on June 12, 2026 after a review of 25 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all SteriLance Medical (Suzhou), Inc. devices

Submission Details

510(k) Number K261634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2026
Decision Date June 12, 2026
Days to Decision 25 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 115d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 15
Devices cleared under the same product code (QRK) and FDA review panel - the closest regulatory comparables to K261634.
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
MICROLET®NEXT Lancet
K241810 · Ascensia Diabetes Care U.S., Inc. · Aug 2024
Lancing System
K232330 · Ningbo Medsun Medical Co., Ltd. · Jan 2024
SG Lanset I, SG Lancets, Soft Lancets
K230712 · Sewon Medical Co. · Dec 2023