Cleared Traditional

K934796 - IPI LOW PROFILE IMPORT

K934796 is the FDA 510(k) clearance for IPI LOW PROFILE IMPORT by Pudenz-Schulte Medical Research Corp.. It is a Class 2 General Hospital device (product code LJT) cleared through the Traditional 510(k) pathway after a 281-day FDA review.

K934796 · Pudenz-Schulte Medical Research Corp. · General Hospital
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Optimized for regulatory review, auditing and printing
Jul 1994
Decision
281d
Days
Class 2
Risk

K934796 is an FDA 510(k) clearance for the IPI LOW PROFILE IMPORT. 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 281 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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

Submission Details

510(k) Number K934796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1993
Decision Date July 14, 1994
Days to Decision 281 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
152d slower than avg
Panel avg: 129d · This submission: 281d
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 109
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K934796.
STRATO MEDICAL INFUSE-A-PORT/INFUSE-A-KIT PERIPORT PERIPHERAL ACCESS SYSTEM
K934518 · Strato Medical Corp. · Jan 1995
PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS ACCESS SYSTEM
K942024 · Pharmacia Deltec, Inc. · Jul 1994
IPI DUAL LUMEN PORT
K934167 · Pudenz-Schulte Medical Research Corp. · Jul 1994
PS MEDICAL IPI ACCESS KIT
K930206 · Pudenz-Schulte Medical Research Corp. · Feb 1994
STRATO MEDICAL INFUSE-A-PORT/SNAP-LOCK MACROPRORT
K932509 · Strato Medical Corp. · Jan 1994
PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS ACCESS S
K932095 · Pharmacia Deltec, Inc. · Jan 1994