Cleared Traditional

K091213 - FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN

K091213 is an FDA 510(k) clearance for FOOTPRINT MEDICAL UMBILICAL CATHETER, manufactured by Footprint Medical. The device is a Class 2 General Hospital device with product code FOS cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K091213 · Footprint Medical · General Hospital
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Sep 2009
Decision
151d
Days
Class 2
Risk

K091213 is an FDA 510(k) clearance for the FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN. Classified as Catheter, Umbilical Artery (product code FOS), Class II - Special Controls.

Submitted by Footprint Medical (San Antonio, US). The FDA issued a Cleared decision on September 25, 2009 after a review of 151 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - the FDA general hospital device 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Footprint Medical devices

FDA 510(k) Submission Details - K091213

510(k) Number K091213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2009
Decision Date September 25, 2009
Days to Decision 151 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 129d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 30
Devices cleared under the same product code (FOS) and FDA review panel - the closest regulatory comparables to K091213.
Umbilical Vessels Catheter
K201697 · Haolang Medical USA Corporation · May 2021
MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR.
K130725 · Covidien Lp, Formerly Registered AS Kendall · Apr 2013
FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER
K120304 · Footprint Medical, Inc. · Mar 2012
FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER
K091214 · Footprint Medical · Sep 2009
NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0
K081515 · Neomed, Inc. · Jul 2008
NEOMED SINGLE LUMEN UMBILICAL CATHETER
K073596 · Neomed, Inc. · Feb 2008