Cleared Traditional

K022753 - REPROCESSES USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS

K022753 is an FDA 510(k) clearance for REPROCESSES USED DISPOSABLE SEQUENTIAL ..., manufactured by Medical Device Services. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K022753 · Medical Device Services · Cardiovascular device
Download Printable Device Report (PDF)
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Nov 2002
Decision
87d
Days
Class 2
Risk

K022753 is an FDA 510(k) clearance for the REPROCESSES USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Medical Device Services (St. George, US). The FDA issued a Cleared decision on November 14, 2002 after a review of 87 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 Medical Device Services devices

FDA 510(k) Submission Details - K022753

510(k) Number K022753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2002
Decision Date November 14, 2002
Days to Decision 87 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
38d faster than avg
Panel avg: 125d · This submission: 87d
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 324
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K022753.
REPROCESSED COMPRESSION SLEEVE
K021654 · Alliance Medical, Inc. · Feb 2003
HYGIA HEALTH SERVICES REPROCESSED NOVAMEDIX IMPAB MODELS 5065, 5075, 5087, 5089
K021509 · Hygia Health Services, Inc. · Dec 2002
WIZAIR COMPRESSION SYSTEM
K023573 · Medical Compression Systems (Dbn) , Ltd. · Nov 2002
DVT60
K022786 · Huntleigh Healthcare, Inc. · Sep 2002
REPROCESSED VENODYNE SEQUENTIAL COMPRESSION SLEEVES / WRAP
K021528 · Adven Medical · Aug 2002
BODY FORCE, MODEL BT 6000
K020211 · Composites Solutions, Inc. · Jun 2002