Cleared Special

PowerGlide Pro Midline Catheter (K162377) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 138
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K162377.
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
AccuCath Intravascular Catheter
K162894 · C.R. Bard, Inc. · Nov 2016
PowerGlide Pro Midline Catheter
K153280 · C.R. Bard, Inc. · Jun 2016
AccuCath Intravascular Catheter
K153298 · C.R. Bard, Inc. · Dec 2015
POWERGLIDE MIDLINE CATHETER
K133856 · C.R. Bard, Inc. · Jan 2014