Cleared Traditional

K911997 - TENDERFOOT(R), MODIFICATION

K911997 is an FDA 510(k) clearance for TENDERFOOT, manufactured by International Technidyne Corp.. The device is a Class 2 Hematology device with product code FMK cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K911997 · International Technidyne Corp. · Hematology device
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Jul 1991
Decision
86d
Days
Class 2
Risk

K911997 is an FDA 510(k) clearance for the TENDERFOOT(R), MODIFICATION. 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 July 17, 1991 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 878.4850 - the FDA hematology 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 International Technidyne Corp. devices

FDA 510(k) Submission Details - K911997

510(k) Number K911997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1991
Decision Date July 17, 1991
Days to Decision 86 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 113d · This submission: 86d
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 Hematology 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 K911997.
B-D ULTRA FINE(R) LANCET
K932725 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1993
TENDERLETT FINGER
K923302 · International Technidyne Corp. · Jan 1993
UNISTIK
K920562 · Ulster Scientific, Inc. · Mar 1992
GLUCOLET 2 AUTOMATIC LANCING DEVICE FOR OB. BLOOD
K902430 · Heraeus Kulzer, Inc. · Aug 1990
THE AUTOLET LITE
K894474 · Ulster Scientific, Inc. · Aug 1989
TENDERFOOT
K883968 · International Technidyne Corp. · Dec 1988