Cleared Traditional

K244036 - Heel Incision Safety Lancet (SteriHeel 2) (FDA 510(k) Clearance)

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

K244036 · SteriLance Medical (Suzhou), Inc. · General & Plastic Surgery device
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Feb 2025
Decision
58d
Days
Class 2
Risk

K244036 is an FDA 510(k) clearance for the Heel Incision Safety Lancet (SteriHeel 2). 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 February 26, 2025 after a review of 58 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 SteriLance Medical (Suzhou), Inc. devices

Submission Details

510(k) Number K244036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2024
Decision Date February 26, 2025
Days to Decision 58 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
56d faster than avg
Panel avg: 114d · This submission: 58d
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 108
Devices cleared under the same product code (FMK) and FDA review panel - the closest regulatory comparables to K244036.
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K261045 · Promisemed Hangzhou Meditech Co., Ltd. · May 2026
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K253605 · Ningbo Medsun Medical Co., Ltd. · Feb 2026
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K252490 · Tianjin Huahong Technology Co., Ltd. · Feb 2026
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LetsGetChecked Impress
K242680 · Privapath Diagnostics Ltd (Dba Letsgetchecked) · Jan 2025
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