Cleared Special

K130507 - FOOTPRINT MEDICAL POLYURETHANE PICC CAT...

K130507 is an FDA 510(k) clearance for FOOTPRINT MEDICAL POLYURETHANE PICC CAT..., manufactured by Footprint Medical, Inc.. The device is a Class 2 General Hospital device with product code LJS cleared through the Special 510(k) pathway after a 96-day FDA review.

K130507 · Footprint Medical, Inc. · General Hospital
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Jun 2013
Decision
96d
Days
Class 2
Risk

K130507 is an FDA 510(k) clearance for the FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Footprint Medical, Inc. (San Antonio, US). The FDA issued a Cleared decision on June 3, 2013 after a review of 96 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - 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. 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 Footprint Medical, Inc. devices

FDA 510(k) Submission Details - K130507

510(k) Number K130507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2013
Decision Date June 03, 2013
Days to Decision 96 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
33d faster than avg
Panel avg: 129d · This submission: 96d
Pathway characteristics
Modification to existing cleared device.

LJS Device Classification - Class 2, Special Controls

Product Code LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
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 - LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

All 191
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