Cleared Traditional

gentleheel® Adult Incision Device (K242664) - FDA 510(k) Clearance

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

K242664 · Gri-Alleset, Inc. · General & Plastic Surgery device
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Nov 2024
Decision
62d
Days
Class 2
Risk

K242664 is an FDA 510(k) clearance for the gentleheel® Adult Incision Device. Classified as Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature (product code FMK), Class II - Special Controls.

Submitted by Gri-Alleset, Inc. (Flowery Branch, US). The FDA issued a Cleared decision on November 5, 2024 after a review of 62 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 Gri-Alleset, Inc. devices

Submission Details

510(k) Number K242664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2024
Decision Date November 05, 2024
Days to Decision 62 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
53d faster than avg
Panel avg: 115d · This submission: 62d
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 Consultant

Regulatory Resources Group, Inc.
Julie Stephens

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K242664.
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
Safety Lancet
K242627 · Ningbo Medsun Medical Co., Ltd. · Oct 2024
Safety Lancet
K242316 · Ningbo Medsun Medical Co., Ltd. · Aug 2024
MedtFine Safety Lancet
K241848 · Ningbo Caremed Medical Products Co., Ltd. · Aug 2024