Cleared Traditional

K100909 - REPROCESSED COMPRESSION SLEEVES

K100909 is an FDA 510(k) clearance for REPROCESSED COMPRESSION SLEEVES, manufactured by Ascent Healthcare Solutions. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K100909 · Ascent Healthcare Solutions · Cardiovascular device
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Jul 2010
Decision
113d
Days
Class 2
Risk

K100909 is an FDA 510(k) clearance for the REPROCESSED COMPRESSION SLEEVES. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Ascent Healthcare Solutions (Phoenix, US). The FDA issued a Cleared decision on July 23, 2010 after a review of 113 days - within the typical 510(k) review window.

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 Ascent Healthcare Solutions devices

FDA 510(k) Submission Details - K100909

510(k) Number K100909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2010
Decision Date July 23, 2010
Days to Decision 113 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
12d faster than avg
Panel avg: 125d · This submission: 113d
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 247
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K100909.
VENODYNE V810
K110358 · Microtek Medical, Inc. · May 2011
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K103247 · Thermotek, Inc. · Dec 2010
KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER
K102737 · Covidien, LLC · Oct 2010
LYMPHA PRESS 201MAX, MODEL 201MAX
K100677 · Mego Afek AC , Ltd. · May 2010
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