Cleared Traditional

K833822 - P-S MEDICAL CSF ACCESS DEV 15MM/25MM

K833822 is the FDA 510(k) clearance for P-S MEDICAL CSF ACCESS DEV 15MM/25MM by Pudenz-Schulte Medical Research Corp.. It is a Class 2 General Hospital device (product code LKG) cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K833822 · Pudenz-Schulte Medical Research Corp. · General Hospital
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May 1984
Decision
205d
Days
Class 2
Risk

K833822 is an FDA 510(k) clearance for the P-S MEDICAL CSF ACCESS DEV 15MM/25MM. Classified as Port & Catheter, Implanted, Subcutaneous, Intraventricular (product code LKG), Class II - Special Controls.

Submitted by Pudenz-Schulte Medical Research Corp. (Walker, US). The FDA issued a Cleared decision on May 25, 1984 after a review of 205 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 882.5550 - 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 K833822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1983
Decision Date May 25, 1984
Days to Decision 205 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 129d · This submission: 205d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LKG Port & Catheter, Implanted, Subcutaneous, Intraventricular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5550
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 - LKG Port & Catheter, Implanted, Subcutaneous, Intraventricular

Devices cleared under the same product code (LKG) and FDA review panel - the closest regulatory comparables to K833822.
PORT-A-CATH PORTAL INTRODUCER FORCEPS
K881690 · Pharmacia Deltec, Inc. · May 1988
P-S MEDICAL VENTRICULAR ACCESS PORT
K874468 · Pudenz-Schulte Medical Research Corp. · Feb 1988
CSF-VENTRICULOSTOMY RESERVOIR
K874498 · Pudenz-Schulte Medical Research Corp. · Feb 1988
HH SUBCUTANEOUS ACCESS PORT
K833672 · Holter-Hausner Intl. · Mar 1984