Cleared Traditional

K253605 - Safety Heel Lancet (FDA 510(k) Clearance)

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

K253605 · Ningbo Medsun Medical Co., Ltd. · General & Plastic Surgery device
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Feb 2026
Decision
94d
Days
Class 2
Risk

K253605 is an FDA 510(k) clearance for the Safety Heel Lancet. Classified as Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature (product code FMK), Class II - Special Controls.

Submitted by Ningbo Medsun Medical Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on February 20, 2026 after a review of 94 days - within the typical 510(k) review window.

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 Ningbo Medsun Medical Co., Ltd. devices

Submission Details

510(k) Number K253605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2025
Decision Date February 20, 2026
Days to Decision 94 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
20d faster than avg
Panel avg: 114d · This submission: 94d
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 K253605.
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K261045 · Promisemed Hangzhou Meditech Co., Ltd. · May 2026
Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)
K252490 · Tianjin Huahong Technology Co., Ltd. · Feb 2026
safety lancet
K251694 · Tianjin Huahong Technology Co., Ltd. · Jun 2025
Heel Incision Safety Lancet (SteriHeel 2)
K244036 · SteriLance Medical (Suzhou), Inc. · Feb 2025
LetsGetChecked Impress
K242680 · Privapath Diagnostics Ltd (Dba Letsgetchecked) · Jan 2025
Sterilized Eol Auto Lancet
K243533 · Hlb Co., Ltd. Healthcare · Jan 2025