Cleared Traditional

K073013 - CTU676 DEVICE

K073013 is an FDA 510(k) clearance for CTU676 DEVICE, manufactured by Compression Technologies Unlimited, Inc.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K073013 · Compression Technologies Unlimited, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
27d
Days
Class 2
Risk

K073013 is an FDA 510(k) clearance for the CTU676 DEVICE. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Compression Technologies Unlimited, Inc. (Lansing, US). The FDA issued a Cleared decision on November 21, 2007 after a review of 27 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 Compression Technologies Unlimited, Inc. devices

FDA 510(k) Submission Details - K073013

510(k) Number K073013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2007
Decision Date November 21, 2007
Days to Decision 27 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 125d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 166
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K073013.
COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS
K100521 · Mego Afek AC , Ltd. · May 2010
KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES
K100306 · Covidien · May 2010
LYMPHA PRESS OPTIMAL, MODEL# 1201AP
K082149 · Mego Afek AC , Ltd. · Oct 2008
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