Cleared Traditional

K101087 - REPROCESSED RESTEP COMPRESSION SLEEVES

K101087 is an FDA 510(k) clearance for REPROCESSED RESTEP COMPRESSION SLEEVES, manufactured by Ascent Heatlhcare Solutions. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K101087 · Ascent Heatlhcare Solutions · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
88d
Days
Class 2
Risk

K101087 is an FDA 510(k) clearance for the REPROCESSED RESTEP COMPRESSION SLEEVES. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Ascent Heatlhcare Solutions (Phoenix, US). The FDA issued a Cleared decision on July 16, 2010 after a review of 88 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.

FDA 510(k) Submission Details - K101087

510(k) Number K101087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2010
Decision Date July 16, 2010
Days to Decision 88 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
37d faster than avg
Panel avg: 125d · This submission: 88d
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 342
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K101087.
MIDWEST REPROCESSING CENTER REPROCESSED VENODYNE SLEEVES/FOOT CUFFS
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K101523 · Devon Medical, Inc. · Jun 2010
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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
K101087 · REPROCESSED RESTEP COMPRESSION SLEEVES
Download PDF FDA Summary Ascent Heatlhcare Sol…