Cleared Traditional

K121145 - RENU MEDICAL REPROCESSED AIRCAST VENAFL...

K121145 is an FDA 510(k) clearance for RENU MEDICAL REPROCESSED AIRCAST VENAFL..., 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 57-day FDA review.

K121145 · Renu Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
57d
Days
Class 2
Risk

K121145 is an FDA 510(k) clearance for the RENU MEDICAL REPROCESSED AIRCAST VENAFLOW CALF GARMENTS/ALL SIZES, RENU MEDIC.... 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 June 12, 2012 after a review of 57 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Renu Medical, Inc. devices

FDA 510(k) Submission Details - K121145

510(k) Number K121145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2012
Decision Date June 12, 2012
Days to Decision 57 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
68d faster than avg
Panel avg: 125d · This submission: 57d
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 K121145.
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