Cleared Special

K122330 - FLOWTRON FOOT GARMENT-REGULAR-STERILE FLOWTRON FOOT GARMENT-LARGE-STERILE

K122330 is an FDA 510(k) clearance for FLOWTRON FOOT GARMENT-REGULAR-STERILE F..., manufactured by Arjohuntleigh Polska SP Z.O.O.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Special 510(k) pathway after a 127-day FDA review.

K122330 · Arjohuntleigh Polska SP Z.O.O. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
127d
Days
Class 2
Risk

K122330 is an FDA 510(k) clearance for the FLOWTRON FOOT GARMENT-REGULAR-STERILE FLOWTRON FOOT GARMENT-LARGE-STERILE. 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 December 7, 2012 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5800 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Arjohuntleigh Polska SP Z.O.O. devices

FDA 510(k) Submission Details - K122330

510(k) Number K122330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2012
Decision Date December 07, 2012
Days to Decision 127 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 125d · This submission: 127d
Pathway characteristics
Modification to existing cleared device.

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 126
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