Cleared Traditional

K931828 - CARELET SAFETY LANCET

K931828 is the FDA 510(k) clearance for CARELET SAFETY LANCET by Gainor Medical Europe, Ltd.. It is a Class 2 General & Plastic Surgery device (product code FMK) cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K931828 · Gainor Medical Europe, Ltd. · General & Plastic Surgery device
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Oct 1993
Decision
190d
Days
Class 2
Risk

K931828 is an FDA 510(k) clearance for the CARELET 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 Gainor Medical Europe, Ltd. (Mcdonough, US). The FDA issued a Cleared decision on October 15, 1993 after a review of 190 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 Gainor Medical Europe, Ltd. devices

Submission Details

510(k) Number K931828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1993
Decision Date October 15, 1993
Days to Decision 190 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 115d · This submission: 190d
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 65
Devices cleared under the same product code (FMK) and FDA review panel - the closest regulatory comparables to K931828.
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
MONOJECT(R) MONOLETTOR SAFETY LANCET
K932785 · Sherwood Medical Co. · Sep 1993
B-D ULTRA FINE(R) LANCET
K932725 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1993
GLUCOLET 2 AUTOMATIC LANCING DEVICE FOR OB. BLOOD
K902430 · Heraeus Kulzer, Inc. · Aug 1990