Cleared Special

K113429 - SAFETOUCH PSV WINGED INFUSION SET, AND SET WITH FILTER

K113429 is an FDA 510(k) clearance for SAFETOUCH PSV WINGED INFUSION SET, manufactured by Nipro Medical Corporation. The device is a Class 2 General Hospital device with product code FOZ cleared through the Special 510(k) pathway after a 112-day FDA review.

K113429 · Nipro Medical Corporation · General Hospital
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Mar 2012
Decision
112d
Days
Class 2
Risk

K113429 is an FDA 510(k) clearance for the SAFETOUCH PSV WINGED INFUSION SET, AND SET WITH FILTER. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Nipro Medical Corporation (Miami, US). The FDA issued a Cleared decision on March 12, 2012 after a review of 112 days - within the typical 510(k) review window.

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. 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 Nipro Medical Corporation devices

FDA 510(k) Submission Details - K113429

510(k) Number K113429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2011
Decision Date March 12, 2012
Days to Decision 112 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 129d · This submission: 112d
Pathway characteristics
Modification to existing cleared device.

FOZ Device Classification - Class 2, Special Controls

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
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 - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

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