Cleared Traditional

DIGIKIT NONPNEUMATIC TOURNIQUET (K860095) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

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 33
Devices cleared under the same product code (KCY) and FDA review panel - the closest regulatory comparables to K860095.
ATS 5000 Automatic Tourniquet Instrument
K202919 · Mcewen and Associates Consulting , Ltd. · May 2021
ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM
K123553 · Zimmer, Inc. · Aug 2013
ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM
K050411 · Zimmer, Inc. · Sep 2005
ARTHREX TOURNIQUET FOR LEG HOLDER
K933994 · Arthrex, Inc. · Mar 1994
TEST PRESSURE GAUGE #6675-32
K791759 · Depuy, Inc. · Oct 1979