Cleared Traditional

Heel Incision Safety Lancet (K210745) - FDA 510(k) Clearance

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

K210745 · SteriLance Medical (Suzhou), Inc. · General & Plastic Surgery device
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Aug 2021
Decision
167d
Days
Class 2
Risk

K210745 is an FDA 510(k) clearance for the Heel Incision Safety Lancet. Classified as Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature (product code FMK), Class II - Special Controls.

Submitted by SteriLance Medical (Suzhou), Inc. (Suzhou, CN). The FDA issued a Cleared decision on August 26, 2021 after a review of 167 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 K210745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2021
Decision Date August 26, 2021
Days to Decision 167 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
52d slower than avg
Panel avg: 115d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMK Single Use Only Blood Lancet With 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, Non-reusable Base (including An Integral Sharps Injury Prevention Feature) That Is Used To Puncture The Skin To Obtain A Drop Of Blood For Diagnostic Purposes. The Integral Sharps Injury Prevention Feature Allows The Device To Be Used Once And Then Renders It Inoperable And Incapable Of Further Use.
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 - FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

All 63
Devices cleared under the same product code (FMK) and FDA review panel - the closest regulatory comparables to K210745.
gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler
K220917 · Gri-Alleset, Inc. · May 2022
Heel Stick Safety Lancet (HHZ-II, HHZ-III)
K220372 · Tianjin Huahong Technology Co., Ltd. · May 2022
Accu-Chek Safe-T-Pro Uno Lancing Device
K220364 · Roche Diabetes Care, Inc. · Apr 2022
Promisemed Heel Blood Lancet
K193009 · Promisemed Hangzhou Meditech Co., Ltd. · Dec 2019
Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet
K192666 · Promisemed Hangzhou Meditech Co., Ltd. · Dec 2019
SOFTTOUCH II LANCET DEVICE
K931258 · Boehringer Mannheim Corp. · Feb 1994