Cleared Traditional

K031189 - UUHC REPROCESSED COMPRESSION SLEEVE DEVICES

K031189 is an FDA 510(k) clearance for UUHC REPROCESSED COMPRESSION SLEEVE DEVICES, manufactured by University of Utah Hospitals and Clinics. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K031189 · University of Utah Hospitals and Clinics · Cardiovascular device
Download Printable Device Report (PDF)
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Oct 2003
Decision
184d
Days
Class 2
Risk

K031189 is an FDA 510(k) clearance for the UUHC REPROCESSED COMPRESSION SLEEVE DEVICES. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by University of Utah Hospitals and Clinics (Salt Lake City, US). The FDA issued a Cleared decision on October 16, 2003 after a review of 184 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5800 - the FDA cardiovascular device 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all University of Utah Hospitals and Clinics devices

FDA 510(k) Submission Details - K031189

510(k) Number K031189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2003
Decision Date October 16, 2003
Days to Decision 184 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 125d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOW Device Classification - Class 2, Special Controls

Product Code JOW Sleeve, Limb, Compressible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5800
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - JOW Sleeve, Limb, Compressible

All 325
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K031189.
C-BOOT
K041659 · C-Boot , Ltd. · Oct 2004
JSA REPROCESSED COMPRESSION SLEEVE DEVICES
K031722 · Jack Speer and Assoc., Inc. · Nov 2003
RENU MEDICAL REPORCESSED COMPRESSIBLE LIMB SLEEVES
K031559 · Renu Medical, Inc. · Nov 2003
ARTERIALFLOW SYSTEM, MODEL 32A
K024019 · Aircast, Inc. · Jun 2003
REPROCESSED COMPRESSION SLEEVES
K024087 · Alliance Medical Corp. · Mar 2003
REPROCESSED COMPRESSION SLEEVES
K024074 · Alliance Medical Corp. · Mar 2003