Cleared Traditional

babyLance Safety Heelstick (BLM, BLN, BLP) (K223900) - FDA 510(k) Clearance

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

K223900 · Clinical Innovations, LLC · General & Plastic Surgery device
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Feb 2023
Decision
58d
Days
Class 2
Risk

K223900 is an FDA 510(k) clearance for the babyLance Safety Heelstick (BLM, BLN, BLP). Classified as Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature (product code FMK), Class II - Special Controls.

Submitted by Clinical Innovations, LLC (Murray, US). The FDA issued a Cleared decision on February 24, 2023 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 Clinical Innovations, LLC devices

Submission Details

510(k) Number K223900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2022
Decision Date February 24, 2023
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
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 115d · 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 63
Devices cleared under the same product code (FMK) and FDA review panel - the closest regulatory comparables to K223900.
Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G)
K231124 · Owen Mumford, Ltd. · Jun 2023
TAP Lancet
K223201 · Yourbio Health, Inc. · Apr 2023
Tenderfoot
K223352 · Accriva Diagnostics, Inc. · Mar 2023
NeatNick Heel Safety Lancet
K223370 · Facet Technologies, LLC · Feb 2023
Safety Lancet
K223208 · Suzhou Zhenwu Medical Co., Ltd. · Feb 2023
Safety Lancet
K222801 · Sarstedt AG & CO KG · Jan 2023