Cleared Traditional

K133119 - FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTS

K133119 is an FDA 510(k) clearance for FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTS, manufactured by Arjohuntleigh Polska SP Z.O.O.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K133119 · Arjohuntleigh Polska SP Z.O.O. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
151d
Days
Class 2
Risk

K133119 is an FDA 510(k) clearance for the FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTS. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Arjohuntleigh Polska SP Z.O.O. (Cardiff, GB). The FDA issued a Cleared decision on February 28, 2014 after a review of 151 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.

FDA 510(k) Submission Details - K133119

510(k) Number K133119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2013
Decision Date February 28, 2014
Days to Decision 151 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
26d slower than avg
Panel avg: 125d · This submission: 151d
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 342
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K133119.
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K133119 · FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTS
Download PDF FDA Summary Arjohuntleigh Polska …