Cleared Special

K130132 - BABYLANCE HEEL INCISION DEVICE

K130132 is an FDA 510(k) clearance for BABYLANCE HEEL INCISION DEVICE, manufactured by Medipurpose Pte. , Ltd.. The device is a Class 2 General & Plastic Surgery device with product code FMK cleared through the Special 510(k) pathway after a 24-day FDA review.

K130132 · Medipurpose Pte. , Ltd. · General & Plastic Surgery device
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Feb 2013
Decision
24d
Days
Class 2
Risk

K130132 is an FDA 510(k) clearance for the BABYLANCE HEEL 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 Medipurpose Pte. , Ltd. (Alpharetta, US). The FDA issued a Cleared decision on February 11, 2013 after a review of 24 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medipurpose Pte. , Ltd. devices

FDA 510(k) Submission Details - K130132

510(k) Number K130132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2013
Decision Date February 11, 2013
Days to Decision 24 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 115d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

FMK Device Classification - Class 2, Special Controls

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 70
Devices cleared under the same product code (FMK) and FDA review panel - the closest regulatory comparables to K130132.
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