Cleared Traditional

K113513 - PLANCET

K113513 is the FDA 510(k) clearance for PLANCET by Micropoint Technologies Pte, Ltd.. It is a Class 2 General & Plastic Surgery device (product code FMK) cleared through the Traditional 510(k) pathway after a 228-day FDA review.

K113513 · Micropoint Technologies Pte, Ltd. · General & Plastic Surgery device
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Jul 2012
Decision
228d
Days
Class 2
Risk

K113513 is an FDA 510(k) clearance for the PLANCET. Classified as Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature (product code FMK), Class II - Special Controls.

Submitted by Micropoint Technologies Pte, Ltd. (Singapore, SG). The FDA issued a Cleared decision on July 13, 2012 after a review of 228 days - an extended review 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: 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 Micropoint Technologies Pte, Ltd. devices

Submission Details

510(k) Number K113513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2011
Decision Date July 13, 2012
Days to Decision 228 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
113d slower than avg
Panel avg: 115d · This submission: 228d
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 70
Devices cleared under the same product code (FMK) and FDA review panel - the closest regulatory comparables to K113513.
Heel Incision Safety Lancet
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Promisemed Heel Blood Lancet
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Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet
K192666 · Promisemed Hangzhou Meditech Co., Ltd. · Dec 2019
ON CALL CHOSEN LANCING DEVICE
K113332 · ACON Laboratories, Inc. · Apr 2012
SOFTTOUCH II LANCET DEVICE
K931258 · Boehringer Mannheim Corp. · Feb 1994
BABISTICK
K933365 · Graphic Controls Corp. · Oct 1993