Cleared Traditional

K060049 - REPROCESSED COMPRESSION SLEEVES

K060049 is an FDA 510(k) clearance for REPROCESSED COMPRESSION SLEEVES, manufactured by Alliance Medical Corp.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K060049 · Alliance Medical Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
49d
Days
Class 2
Risk

K060049 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 Alliance Medical Corp. (Phoenix, US). The FDA issued a Cleared decision on February 24, 2006 after a review of 49 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 Alliance Medical Corp. devices

FDA 510(k) Submission Details - K060049

510(k) Number K060049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2006
Decision Date February 24, 2006
Days to Decision 49 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
76d faster than avg
Panel avg: 125d · This submission: 49d
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 323
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K060049.
RENU MEDICAL REPROCESSED ALP 1 CALF GARMENT, MODEL ALP1
K051227 · Renu Medical, Inc. · Apr 2006
VANGUARD REPROCESSED COMPRESSION GARMENTS (HILL-ROM)
K051438 · Alliance Medical, Inc. · Apr 2006
ACTIVECARE ++ SYSTEM
K060146 · Medical Compression Systems (Dbn) , Ltd. · Mar 2006
ALLIANCE MEDICAL CORPORATION REPROCESSED COMPRESSION SLEEVES
K060091 · Alliance Medical Corp. · Feb 2006
HYGIA HEALTH SERVICES REPROCESSED KENDALL SCD EXPRESS SLEEVES/FOOT CUFFS
K053575 · Hygia Health Services, Inc. · Feb 2006
REPROCESSED COMPRESSION SLEEVES
K053316 · Alliance Medical Corp. · Feb 2006