Cleared Traditional

K930206 - PS MEDICAL IPI ACCESS KIT

K930206 is the FDA 510(k) clearance for PS MEDICAL IPI ACCESS KIT 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 406-day FDA review.

K930206 · Pudenz-Schulte Medical Research Corp. · General Hospital
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Optimized for regulatory review, auditing and printing
Feb 1994
Decision
406d
Days
Class 2
Risk

K930206 is an FDA 510(k) clearance for the PS MEDICAL IPI ACCESS KIT. 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 February 25, 1994 after a review of 406 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 Pudenz-Schulte Medical Research Corp. devices

Submission Details

510(k) Number K930206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received January 15, 1993
Decision Date February 25, 1994
Days to Decision 406 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
277d slower than avg
Panel avg: 129d · This submission: 406d
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 K930206.
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K934796 · Pudenz-Schulte Medical Research Corp. · Jul 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
PORT-A-CATH IMPLANTABLE VASCULAR ACCESS SYSTEM
K932840 · Pharmacia Deltec, Inc. · Jan 1994