Cleared Traditional

K181446 - Bard Power-Injectable Implantable Ports (PowerPorts®) (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K181446 · C.R. Bard, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
402d
Days
Class 2
Risk

K181446 is an FDA 510(k) clearance for the Bard Power-Injectable Implantable Ports (PowerPorts®). Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on July 8, 2019 after a review of 402 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5965 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K181446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2018
Decision Date July 08, 2019
Days to Decision 402 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
274d slower than avg
Panel avg: 128d · This submission: 402d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5965
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 - LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

All 286
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K181446.
Vaccess™ CT Low-Profile Power-Injectable Implantable Port
K252478 · Bard Access Systems, Inc. · Sep 2025
PowerPort™ isp Implantable Port
K251253 · Bard Access Systems, Inc. · Jun 2025
PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports
K242328 · Bard Access Systems, Inc. · Oct 2024
PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port
K232737 · Bard Peripheral Vascular, Inc. · Dec 2023
SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports
K190559 · AngioDynamics, Inc. · May 2020