Cleared Traditional

K860095 - DIGIKIT NONPNEUMATIC TOURNIQUET

K860095 is the FDA 510(k) clearance for DIGIKIT NONPNEUMATIC TOURNIQUET by Orthofab, Inc.. It is a Class 1 General & Plastic Surgery device (product code KCY) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K860095 · Orthofab, Inc. · General & Plastic Surgery device
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Jan 1986
Decision
14d
Days
Class 1
Risk

K860095 is an FDA 510(k) clearance for the DIGIKIT NONPNEUMATIC TOURNIQUET. Classified as Tourniquet, Pneumatic (product code KCY), Class I - General Controls.

Submitted by Orthofab, Inc. (Cottage Grove, US). The FDA issued a Cleared decision on January 24, 1986 after a review of 14 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5910 - 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: 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 Orthofab, Inc. devices

Submission Details

510(k) Number K860095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1986
Decision Date January 24, 1986
Days to Decision 14 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 115d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KCY Tourniquet, Pneumatic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.5910
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KCY Tourniquet, Pneumatic

All 15
Devices cleared under the same product code (KCY) and FDA review panel - the closest regulatory comparables to K860095.
TCPM II TOURNIQUET CUFF PRESSURE MONITOR
K900104 · Electromedics, Inc. · Mar 1990
A.T.S. 1500 TOURNIQUET
K870784 · Aspen Laboratories, Inc. · Mar 1987
SINGLE AND DUAL TOURNIQUET CUFF
K860463 · Aspen Laboratories, Inc. · Feb 1986
ATS 500 TOURNIQUET
K853802 · Aspen Laboratories, Inc. · Oct 1985
BANANA CUFF
K841558 · Aspen Laboratories, Inc. · Jul 1984
PRESSURE SENTRY TOURNIQUET
K840206 · Richards Medical Co., Inc. · Apr 1984