Cleared Traditional

K923302 - TENDERLETT FINGER

K923302 is an FDA 510(k) clearance for TENDERLETT FINGER, manufactured by International Technidyne Corp.. The device is a Class 2 General & Plastic Surgery device with product code FMK cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K923302 · International Technidyne Corp. · General & Plastic Surgery device
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Jan 1993
Decision
200d
Days
Class 2
Risk

K923302 is an FDA 510(k) clearance for the TENDERLETT FINGER. Classified as Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature (product code FMK), Class II - Special Controls.

Submitted by International Technidyne Corp. (Edison, US). The FDA issued a Cleared decision on January 22, 1993 after a review of 200 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 International Technidyne Corp. devices

FDA 510(k) Submission Details - K923302

510(k) Number K923302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1992
Decision Date January 22, 1993
Days to Decision 200 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 115d · This submission: 200d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 76
Devices cleared under the same product code (FMK) and FDA review panel - the closest regulatory comparables to K923302.
BABISTICK
K933365 · Graphic Controls Corp. · Oct 1993
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
UNISTIK
K920562 · Ulster Scientific, Inc. · Mar 1992
TENDERFOOT(R), MODIFICATION
K911997 · International Technidyne Corp. · Jul 1991
GLUCOLET 2 AUTOMATIC LANCING DEVICE FOR OB. BLOOD
K902430 · Heraeus Kulzer, Inc. · Aug 1990