Cleared Special

K162377 - PowerGlide Pro Midline Catheter

K162377 is an FDA 510(k) clearance for PowerGlide Pro Midline Catheter, manufactured by C.R. Bard, Inc.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Special 510(k) pathway after a 29-day FDA review.

K162377 · C.R. Bard, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
29d
Days
Class 2
Risk

K162377 is an FDA 510(k) clearance for the PowerGlide Pro Midline Catheter. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on September 22, 2016 after a review of 29 days - a notably fast clearance cycle.

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. 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 C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K162377

510(k) Number K162377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2016
Decision Date September 22, 2016
Days to Decision 29 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
100d faster than avg
Panel avg: 129d · This submission: 29d
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 320
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K162377.
Nipro SafeTouch IV Catheter
K161681 · Nipro Medical Corporation · Mar 2017
BD Nexiva Diffusics Closed IV Catheter System
K170283 · Becton, Dickinson and Company · Feb 2017
AccuCath Intravascular Catheter
K162894 · C.R. Bard, Inc. · Nov 2016
BioFlo Midline Catheter
K161866 · Navilyst Medical, Inc. · Sep 2016
BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems
K161777 · Becton Dickinson Infusion Therapy Systems, Inc. · Aug 2016
ViaValve Safety I.V. Catheter
K160235 · Smiths Medical Asd, Inc. · Jun 2016