Cleared Traditional

K080551 - UNIVERSITY HEALTH CARE PROCESSED ALTERN...

K080551 is an FDA 510(k) clearance for UNIVERSITY HEALTH CARE PROCESSED ALTERN..., 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 90-day FDA review.

K080551 · University of Utah Hospitals and Clinics · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
90d
Days
Class 2
Risk

K080551 is an FDA 510(k) clearance for the UNIVERSITY HEALTH CARE PROCESSED ALTERNATING LEG PRESSURE (UHC APL) SLEEVE DE.... 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 May 28, 2008 after a review of 90 days - within the typical 510(k) review window.

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 - K080551

510(k) Number K080551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2008
Decision Date May 28, 2008
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
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 124
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K080551.
VENODYNE V810
K110358 · Microtek Medical, Inc. · May 2011
KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER
K102737 · Covidien, LLC · Oct 2010
KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES
K100306 · Covidien · May 2010
REPROCESSED COMPRESSION SLEEVES
K060049 · Alliance Medical Corp. · Feb 2006
ALLIANCE MEDICAL CORPORATION REPROCESSED COMPRESSION SLEEVES
K060091 · Alliance Medical Corp. · Feb 2006
REPROCESSED COMPRESSION SLEEVES
K053316 · Alliance Medical Corp. · Feb 2006