Cleared Special

K162900 - PowerMidline Catheter (FDA 510(k) Clearance)

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

K162900 · C.R. Bard, Inc. · General Hospital
Download Printable Device Report (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.

View all C.R. Bard, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 128d · This submission: 58d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.
Midline Catheter
K252402 · Terumo Medical Products Hangzhou Co., Ltd. · Dec 2025
Arrow Pressure Injectable Midline Catheter
K213855 · Arrow International, LLC Subsidiary of Teleflex Incorporated · Sep 2022
Provena(TM) Midline Catheter
K213203 · C.R. Bard, Inc. · May 2022
Stiletto Extended Dwell Catheter
K210047 · Piper Access, LLC · Aug 2021
primeMidline Catheters
K192802 · Pfm Medical, Inc. · Oct 2019