Cleared Traditional

K031559 - RENU MEDICAL REPORCESSED COMPRESSIBLE L...

K031559 is an FDA 510(k) clearance for RENU MEDICAL REPORCESSED COMPRESSIBLE L..., manufactured by Renu Medical, Inc.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K031559 · Renu Medical, Inc. · Cardiovascular device
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Nov 2003
Decision
177d
Days
Class 2
Risk

K031559 is an FDA 510(k) clearance for the RENU MEDICAL REPORCESSED COMPRESSIBLE LIMB SLEEVES. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Renu Medical, Inc. (Everett, US). The FDA issued a Cleared decision on November 12, 2003 after a review of 177 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 Renu Medical, Inc. devices

FDA 510(k) Submission Details - K031559

510(k) Number K031559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2003
Decision Date November 12, 2003
Days to Decision 177 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
52d slower than avg
Panel avg: 125d · This submission: 177d
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 123
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K031559.
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
REPROCESSED COMPRESSION SLEEVES
K024087 · Alliance Medical Corp. · Mar 2003
REPROCESSED COMPRESSION SLEEVES
K024074 · Alliance Medical Corp. · Mar 2003
STERILMED REPROCESSED COMPRESSION SLEEVES
K012597 · Sterilmed, Inc. · Feb 2002