Cleared Traditional

K161681 - Nipro SafeTouch IV Catheter

K161681 is an FDA 510(k) clearance for Nipro SafeTouch IV Catheter, manufactured by Nipro Medical Corporation. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K161681 · Nipro Medical Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
264d
Days
Class 2
Risk

K161681 is an FDA 510(k) clearance for the Nipro SafeTouch IV Catheter. 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 8, 2017 after a review of 264 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 Nipro Medical Corporation devices

FDA 510(k) Submission Details - K161681

510(k) Number K161681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2016
Decision Date March 08, 2017
Days to Decision 264 days
Submission Type Traditional
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
135d slower than avg
Panel avg: 129d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 399
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K161681.
BD Intima II PLUS Closed IV Catheter System
K172204 · Becton, Dickinson and Company · Aug 2017
Introcan Safety 3 Closed IV Catheter
K163358 · B.Braun Melsungen AG · Apr 2017
BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector
K170336 · Becton, Dickinson and Company · Mar 2017
BD Nexiva Diffusics Closed IV Catheter System
K170283 · Becton, Dickinson and Company · Feb 2017
Arrow Endurance Extended Dwell Peripheral Catheter System
K163513 · Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · Feb 2017
AccuCath Intravascular Catheter
K162894 · C.R. Bard, Inc. · Nov 2016