Cleared Special

K120304 - FOOTPRINT MEDICAL POLYURETHANE UMBILICA...

K120304 is an FDA 510(k) clearance for FOOTPRINT MEDICAL POLYURETHANE UMBILICA..., manufactured by Footprint Medical, Inc.. The device is a Class 2 General Hospital device with product code FOS cleared through the Special 510(k) pathway after a 29-day FDA review.

K120304 · Footprint Medical, Inc. · General Hospital
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Mar 2012
Decision
29d
Days
Class 2
Risk

K120304 is an FDA 510(k) clearance for the FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER. Classified as Catheter, Umbilical Artery (product code FOS), Class II - Special Controls.

Submitted by Footprint Medical, Inc. (San Antonio, US). The FDA issued a Cleared decision on March 1, 2012 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - the FDA general hospital device 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Footprint Medical, Inc. devices

FDA 510(k) Submission Details - K120304

510(k) Number K120304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2012
Decision Date March 01, 2012
Days to Decision 29 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 129d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

FOS Device Classification - Class 2, Special Controls

Product Code FOS Catheter, Umbilical Artery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 General Hospital devices follow this clearance model.

Regulatory Peers - FOS Catheter, Umbilical Artery

All 15
Devices cleared under the same product code (FOS) and FDA review panel - the closest regulatory comparables to K120304.
Umbilical Vessels Catheter
K201697 · Haolang Medical USA Corporation · May 2021
ARGYLE NEO-SERT HYDROPHILIC POLYURETHANE UMBILICAL VESSEL CATHETER INSERTION TRAY
K954300 · Sherwood Medical Co. · Dec 1995
ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER
K951738 · Sherwood Medical Co. · Sep 1995
ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER INSERTION TRAY
K951737 · Sherwood Medical Co. · Sep 1995
ARGYLE DUAL LUMEN UMBILICAL VESSEL CATHETER
K941814 · Sherwood Medical Co. · Sep 1994
ARGYLE NEO-SERT
K942564 · Sherwood Medical Co. · Aug 1994