Cleared Traditional

K223370 - NeatNick Heel Safety Lancet (FDA 510(k) Clearance)

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

K223370 · Facet Technologies, LLC · General & Plastic Surgery device
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Feb 2023
Decision
101d
Days
Class 2
Risk

K223370 is an FDA 510(k) clearance for the NeatNick Heel 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 Facet Technologies, LLC (Atlanta, US). The FDA issued a Cleared decision on February 13, 2023 after a review of 101 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 Facet Technologies, LLC devices

Submission Details

510(k) Number K223370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2022
Decision Date February 13, 2023
Days to Decision 101 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
13d faster than avg
Panel avg: 114d · This submission: 101d
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 K223370.
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K261045 · Promisemed Hangzhou Meditech Co., Ltd. · May 2026
Safety Heel Lancet
K253605 · Ningbo Medsun Medical Co., Ltd. · Feb 2026
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K252490 · Tianjin Huahong Technology Co., Ltd. · Feb 2026
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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