Cleared Traditional

K131327 - BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM

K131327 is an FDA 510(k) clearance for BIOARTERIAL PLUS ARTERIAL BLOOD FLOW EN..., manufactured by Bio Compression Systems, Inc.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K131327 · Bio Compression Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
71d
Days
Class 2
Risk

K131327 is an FDA 510(k) clearance for the BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Bio Compression Systems, Inc. (Oms River, US). The FDA issued a Cleared decision on July 18, 2013 after a review of 71 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 Bio Compression Systems, Inc. devices

FDA 510(k) Submission Details - K131327

510(k) Number K131327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2013
Decision Date July 18, 2013
Days to Decision 71 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
54d faster than avg
Panel avg: 125d · This submission: 71d
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 316
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K131327.
INTERMITTENT PNEUMATIC COMPRESSION DEVICE
K123830 · Dalian Labtek Science & Development Co., Ltd. · Aug 2013
IC-1545-DL MULTI FLO DVT COMBO INTERMITTENT PNEUMATIC COMPRESSION DEVICE
K131306 · Bio Compression Systems, Inc. · Jul 2013
VASCULAIRE COMPRESSION SYSTEM, VASCULAIRE SLEEVE (FOOT & CALF), VASCULAIRE SLEEVE (CALF)
K131046 · Venous Health Systems, Inc. · Jul 2013
CIRONA DVT FOOT GARMENT
K131743 · Devon Medical, Inc. · Jul 2013
AIRCAST VENAFLOW ELITE SYSTEM
K130722 · Djo, LLC · Jun 2013
ACTITOUCH ACT-ADAPTIVE COMPRESSION THERAPY SYSTEM
K131193 · Tactile Systems Technology, Inc. · Jun 2013