Cleared Special

K162900 - PowerMidline Catheter

K162900 is an FDA 510(k) clearance for PowerMidline Catheter, manufactured by C.R. Bard, Inc.. The device is a Class 2 General Hospital device with product code PND cleared through the Special 510(k) pathway after a 58-day FDA review.

K162900 · C.R. Bard, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
58d
Days
Class 2
Risk

K162900 is an FDA 510(k) clearance for the PowerMidline Catheter. Classified as Midline Catheter (product code PND), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on December 14, 2016 after a review of 58 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.

FDA 510(k) Submission Details - K162900

510(k) Number K162900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2016
Decision Date December 14, 2016
Days to Decision 58 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
71d faster than avg
Panel avg: 129d · This submission: 58d
Pathway characteristics
Modification to existing cleared device.

PND Device Classification - Class 2, Special Controls

Product Code PND Midline Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
Definition The Catheter Is Inserted Into The Peripheral Vascular System For Infusion Of Fluids And Medications For Less Than 28 Days.
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 - PND Midline Catheter

All 12
Devices cleared under the same product code (PND) and FDA review panel - the closest regulatory comparables to K162900.
ArchFlo CT Midline
K171483 · Medcomp (Dba Medical Components, Inc.) · Dec 2017
CT Midline
K170770 · Medical Components, Inc. (dba MedComp) · Jul 2017
PowerGlide ST Midline Catheter
K170158 · C.R. Bard, Inc. · Jun 2017
ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology
K161313 · Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · Aug 2016
PowerMidline Catheter
K153393 · C.R. Bard, Inc. · Jun 2016