Cleared Traditional

K122402 - LPP (LOW PROFILE PORT)

K122402 is an FDA 510(k) clearance for LPP (LOW PROFILE PORT), manufactured by Pfm Medical, Inc.. The device is a Class 2 General Hospital device with product code LJT cleared through the Traditional 510(k) pathway after a 343-day FDA review.

K122402 · Pfm Medical, Inc. · General Hospital
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Jul 2013
Decision
343d
Days
Class 2
Risk

K122402 is an FDA 510(k) clearance for the LPP (LOW PROFILE PORT). Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Pfm Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on July 16, 2013 after a review of 343 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Pfm Medical, Inc. devices

FDA 510(k) Submission Details - K122402

510(k) Number K122402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2012
Decision Date July 16, 2013
Days to Decision 343 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
214d slower than avg
Panel avg: 129d · This submission: 343d
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 235
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K122402.
POLYSITE IMPLANTABLE INFUSION PORTS
K122834 · Perouse Medical · Dec 2013
NMI PORT II CATHETER
K131694 · Navilyst Medical, Inc. · Aug 2013
5F DIGNITY CT TITANIUM PORT
K130923 · Medical Components, Inc. · Jul 2013
NMI PORT
K122767 · Navilyst Medical, Inc. · Apr 2013
CELSITE IMPLANTABLE ACCESS PORT SYSTEMS
K130576 · B. Braun Interventional Systems, Inc. · Apr 2013
POWERPORT CLEARVUE SLIM IMPLANTABLE PORT
K122899 · C.R. Bard, Inc. · Nov 2012