Cleared Traditional

K934167 - IPI DUAL LUMEN PORT

K934167 is an FDA 510(k) clearance for IPI DUAL LUMEN PORT, manufactured by Pudenz-Schulte Medical Research Corp.. The device is a Class 2 General Hospital device with product code LJT cleared through the Traditional 510(k) pathway after a 321-day FDA review.

K934167 · Pudenz-Schulte Medical Research Corp. · General Hospital
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Optimized for regulatory review, auditing and printing
Jul 1994
Decision
321d
Days
Class 2
Risk

K934167 is an FDA 510(k) clearance for the IPI DUAL LUMEN PORT. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Pudenz-Schulte Medical Research Corp. (Goleta, US). The FDA issued a Cleared decision on July 14, 1994 after a review of 321 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 Pudenz-Schulte Medical Research Corp. devices

FDA 510(k) Submission Details - K934167

510(k) Number K934167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1993
Decision Date July 14, 1994
Days to Decision 321 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
192d slower than avg
Panel avg: 129d · This submission: 321d
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 K934167.
THEREX LOW-PROFILE PORT - TITANIUM MODEL
K942412 · Therex Corp. · Aug 1994
PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS ACCESS SYSTEM
K942024 · Pharmacia Deltec, Inc. · Jul 1994
L-CATH CATHETER SYSTEM - PORT L-CATH
K942103 · Luther Medical Products, Inc. · Jul 1994
IPI LOW PROFILE IMPORT
K934796 · Pudenz-Schulte Medical Research Corp. · Jul 1994
THEREX LOW-PROFILE PORT
K934792 · Therex Corp. · Mar 1994
THEREX LOW-PROFILE PORT-TITANIUM
K934802 · Therex Corp. · Mar 1994