Cleared Traditional

K051227 - RENU MEDICAL REPROCESSED ALP 1 CALF GARMENT, MODEL ALP1

K051227 is an FDA 510(k) clearance for RENU MEDICAL REPROCESSED ALP 1 CALF GARMENT, 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 330-day FDA review.

K051227 · Renu Medical, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 2006
Decision
330d
Days
Class 2
Risk

K051227 is an FDA 510(k) clearance for the RENU MEDICAL REPROCESSED ALP 1 CALF GARMENT, MODEL ALP1. 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 April 7, 2006 after a review of 330 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K051227

510(k) Number K051227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2005
Decision Date April 07, 2006
Days to Decision 330 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
205d slower than avg
Panel avg: 125d · This submission: 330d
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 323
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K051227.
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