Cleared Traditional

K902203 - TENCKHOFF PERITONEAL DIALYSIS KIT

K902203 is the FDA 510(k) clearance for TENCKHOFF PERITONEAL DIALYSIS KIT by Akcess Medical Products, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FJG) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K902203 · Akcess Medical Products, Inc. · Gastroenterology & Urology device
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Aug 1990
Decision
77d
Days
Class 2
Risk

K902203 is an FDA 510(k) clearance for the TENCKHOFF PERITONEAL DIALYSIS KIT. Classified as Dialyzer, Parallel Flow (product code FJG), Class II - Special Controls.

Submitted by Akcess Medical Products, Inc. (New Brunswick, US). The FDA issued a Cleared decision on August 1, 1990 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - the FDA gastroenterology and urology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Akcess Medical Products, Inc. devices

Submission Details

510(k) Number K902203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received May 16, 1990
Decision Date August 01, 1990
Days to Decision 77 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 130d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FJG Dialyzer, Parallel Flow
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FJG Dialyzer, Parallel Flow

All 23
Devices cleared under the same product code (FJG) and FDA review panel - the closest regulatory comparables to K902203.
DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9
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