Cleared Traditional

K071140 - MRI COMPATIBLE THIGH TOURNIQUET

K071140 is an FDA 510(k) clearance for MRI COMPATIBLE THIGH TOURNIQUET, manufactured by Top Spins, Inc.. The device is a Class 1 Radiology device with product code KCY cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K071140 · Top Spins, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
44d
Days
Class 1
Risk

K071140 is an FDA 510(k) clearance for the MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002. Classified as Tourniquet, Pneumatic (product code KCY), Class I - General Controls.

Submitted by Top Spins, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on June 7, 2007 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 878.5910 - the FDA radiology and imaging software oversight 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 Top Spins, Inc. devices

FDA 510(k) Submission Details - K071140

510(k) Number K071140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2007
Decision Date June 07, 2007
Days to Decision 44 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 107d · This submission: 44d
Pathway characteristics
Predicate-based equivalence.

KCY Device Classification - Class 1, General Controls

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 K071140.
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
EXPRESSAIRE TORUNIQUET SYSTEM
K955552 · Smith & Nephew Richards, Inc. · Jan 1996
DEROYAL INDUSTRIES, INC. PNEUMATIC TOURNIQUET CUFF
K953953 · Deroyal Industries, Inc. · Sep 1995
ARTHREX TOURNIQUET FOR LEG HOLDER
K933994 · Arthrex, Inc. · Mar 1994