Cleared Traditional

K080551 - UNIVERSITY HEALTH CARE PROCESSED ALTERNATING LEG PRESSURE (UHC APL) SLEEVE DEVICE

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
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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
Combination Product No
PCCP Authorized No
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 325
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K080551.
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