Cleared Traditional

K143317 - Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes) (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K143317 · Currie Medical Specialties, Inc. · Cardiovascular device
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Jan 2015
Decision
62d
Days
Class 2
Risk

K143317 is an FDA 510(k) clearance for the Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes). Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Currie Medical Specialties, Inc. (Rancho Cucamonga, US). The FDA issued a Cleared decision on January 20, 2015 after a review of 62 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 Currie Medical Specialties, Inc. devices

Submission Details

510(k) Number K143317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2014
Decision Date January 20, 2015
Days to Decision 62 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 125d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 349
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K143317.
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K251446 · Manamed, LLC · Sep 2025