Cleared Traditional

K260122 - Lancing Device (PressGo

K260122 is the FDA 510(k) clearance for Lancing Device (PressGo by SteriLance Medical (Suzhou), Inc.. It is a Class 2 General & Plastic Surgery device (product code QRL) cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K260122 · SteriLance Medical (Suzhou), Inc. · General & Plastic Surgery device
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Jul 2026
Decision
172d
Days
Class 2
Risk

K260122 is an FDA 510(k) clearance for the Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep). Classified as Multiple Use Blood Lancet For Single Patient Use Only (product code QRL), Class II - Special Controls.

Submitted by SteriLance Medical (Suzhou), Inc. (Suzhou, CN). The FDA issued a Cleared decision on July 6, 2026 after a review of 172 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all SteriLance Medical (Suzhou), Inc. devices

Submission Details

510(k) Number K260122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2026
Decision Date July 06, 2026
Days to Decision 172 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 115d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QRL Multiple Use Blood Lancet For Single Patient Use Only
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4850
Definition A Multiple Use Capable Blood Lancet Intended For Use On A Single Patient That Is Comprised Of A Single Use Blade Attached To A Solid, Reusable 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 - QRL Multiple Use Blood Lancet For Single Patient Use Only

All 24
Devices cleared under the same product code (QRL) and FDA review panel - the closest regulatory comparables to K260122.
Lancing device (HH-XV-T)
K253706 · Tianjin Huahong Technology Co., Ltd. · Dec 2025
MICROLET®NEXT 2 Lancing Device
K250813 · Ascensia Diabetes Care U.S., Inc. · May 2025
Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX)
K243306 · Tianjin Huahong Technology Co., Ltd. · Nov 2024
Facet Aurora Reusable Lancet Base
K232912 · Facet Technologies, LLC · Jan 2024
Medifun Lancing Device, Model No. LD-E1
K231797 · Medifun Corporation · Nov 2023
Verifine® Ease Lancing Device, Verifine® Lancing Device
K223643 · Promisemed Hangzhou Meditech Co., Ltd. · Feb 2023