Cleared Traditional

K091099 - C-PORT - HP POWER INJECTABLE PORT

K091099 is an FDA 510(k) clearance for C-PORT - HP POWER INJECTABLE PORT, manufactured by Phs Medical GmbH. The device is a Class 2 General Hospital device with product code LJT cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K091099 · Phs Medical GmbH · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
36d
Days
Class 2
Risk

K091099 is an FDA 510(k) clearance for the C-PORT - HP POWER INJECTABLE PORT. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Phs Medical GmbH (Southlake, US). The FDA issued a Cleared decision on May 22, 2009 after a review of 36 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Phs Medical GmbH devices

FDA 510(k) Submission Details - K091099

510(k) Number K091099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2009
Decision Date May 22, 2009
Days to Decision 36 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 129d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJT Device Classification - Class 2, Special Controls

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 219
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K091099.
NORFOLK MEDICAL NORPORT FAMILY OF PORTS
K102385 · Norfolk Medical Products, Inc. · Jan 2011
ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS
K101017 · AngioDynamics, Inc. · Jun 2010
PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS
K093414 · Smiths Medical Asd, Inc. · Mar 2010
POWERPORT DUO M.R.I. IMPLANTED PORT WITH 9.5 FR. DUAL LUMEN CHRONOFLEX POLYURETHANE CATHETER
K090512 · C.R. Bard, Inc. · Mar 2009
SMARTPORT CT VORTEX
K081472 · AngioDynamics, Inc. · Sep 2008
POWERPORT IMPLANTED PORT WITH GROSHONG CATHETER
K081311 · C.R. Bard, Inc. · Jun 2008