Cleared Traditional

K071763 - AMADEUS ADAPTIVE COMPRESSION THERAPY

K071763 is an FDA 510(k) clearance for AMADEUS ADAPTIVE COMPRESSION THERAPY, manufactured by Convatec. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K071763 · Convatec · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
252d
Days
Class 2
Risk

K071763 is an FDA 510(k) clearance for the AMADEUS ADAPTIVE COMPRESSION THERAPY. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Convatec (Skillman, US). The FDA issued a Cleared decision on March 7, 2008 after a review of 252 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 Convatec devices

FDA 510(k) Submission Details - K071763

510(k) Number K071763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2007
Decision Date March 07, 2008
Days to Decision 252 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
127d slower than avg
Panel avg: 125d · This submission: 252d
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 317
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K071763.
HYGIA HEALTH SERVICES REPROCESSED COMPRESSION SLEEVES / FOOT CUFFS
K090074 · Hygia Health Services, Inc. · Apr 2009
LYMPHA PRESS OPTIMAL, MODEL# 1201AP
K082149 · Mego Afek AC , Ltd. · Oct 2008
UNIVERSITY HEALTH CARE PROCESSED ALTERNATING LEG PRESSURE (UHC APL) SLEEVE DEVICE
K080551 · University of Utah Hospitals and Clinics · May 2008
VENOWAVE MODELS VW5-6, VW5-10, VW5-20 AND VW5-30
K073028 · Venowave, Inc. · Mar 2008
PHLEBOPRESS MODEL 601A COMPRESSION THERAPY DEVICE
K072372 · Mego Afek · Nov 2007
CTU676 DEVICE
K073013 · Compression Technologies Unlimited, Inc. · Nov 2007