Cleared Special

K093252 - FOOTPRINT MEDICAL PERIPHERALLY INSERTED...

K093252 is an FDA 510(k) clearance for FOOTPRINT MEDICAL PERIPHERALLY INSERTED..., 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 62-day FDA review.

K093252 · Footprint Medical, Inc. · General Hospital
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Dec 2009
Decision
62d
Days
Class 2
Risk

K093252 is an FDA 510(k) clearance for the FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL 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 December 17, 2009 after a review of 62 days - a notably fast clearance cycle.

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. 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 - K093252

510(k) Number K093252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2009
Decision Date December 17, 2009
Days to Decision 62 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
67d faster than avg
Panel avg: 129d · This submission: 62d
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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