Cleared Traditional

K151158 - ALP VasQcare Take Home System

K151158 is an FDA 510(k) clearance for ALP VasQcare Take Home System, 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 223-day FDA review.

K151158 · Currie Medical Specialties, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
223d
Days
Class 2
Risk

K151158 is an FDA 510(k) clearance for the ALP VasQcare Take Home System. 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 December 10, 2015 after a review of 223 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Currie Medical Specialties, Inc. devices

FDA 510(k) Submission Details - K151158

510(k) Number K151158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2015
Decision Date December 10, 2015
Days to Decision 223 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
98d slower than avg
Panel avg: 125d · This submission: 223d
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
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K151158.
Hydroven 12, Hydroven 12 Garments
K152228 · Huntleigh Healthcare , Ltd. · Apr 2016
PlasmaFlow
K160318 · Manamed, Inc. · Apr 2016
PulseFlowDF
K150806 · Pulseflow Technologies · Dec 2015
Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System
K151189 · Devon Medical Products · Sep 2015
Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC
K150953 · Bio Compression Systems, Inc. · Jul 2015
ActiveCare+SFT
K151377 · Medical Compression System (Dbn) , Ltd. · Jul 2015