Cleared Traditional

K143317 - Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes)

K143317 is an FDA 510(k) clearance for Currie Medical ALP Pediatric Calf Compr..., manufactured by Currie Medical Specialties, Inc.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 62-day FDA review.

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

FDA 510(k) Submission Details - K143317

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
Combination Product No
PCCP Authorized No
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.

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
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