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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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

All 507
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K113429 · SAFETOUCH PSV WINGED INFUSION SET, AND SET WITH FILTER
Download PDF FDA Summary Nipro Medical Corpora…