Cleared Traditional

PERITONEAL DIALYSIS STYSTEM AND ACCESSORIES (K900295) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K900295 · Microwave Medical Systems, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1990
Decision
303d
Days
Class 2
Risk

K900295 is an FDA 510(k) clearance for the PERITONEAL DIALYSIS STYSTEM AND ACCESSORIES. Classified as Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ), Class II - Special Controls.

Submitted by Microwave Medical Systems, Inc. (Littleton, US). The FDA issued a Cleared decision on November 21, 1990 after a review of 303 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5630 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Microwave Medical Systems, Inc. devices

Submission Details

510(k) Number K900295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1990
Decision Date November 21, 1990
Days to Decision 303 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
173d slower than avg
Panel avg: 130d · This submission: 303d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5630
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 - KDJ Set, Administration, For Peritoneal Dialysis, Disposable

All 112
Devices cleared under the same product code (KDJ) and FDA review panel - the closest regulatory comparables to K900295.
stay•safe® catheter extension set with Safe- Lock, 12 inch
K250404 · Fresenius Medical Care Renal Therapies Group, LLC · Apr 2025
MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A
K231849 · Baxter Healthcare · Mar 2024
15L Cycler Drainage Bag
K214016 · Baxter Healthcare Corporation · Mar 2022
MiniCap Extended Life PD Transfer Sets
K192705 · Baxter Healthcare · Oct 2019
stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 6 inch, stay•safe catheter extension set with Luer-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 18 inch, stay•safe to Luer-Lock adapter, 4 inch
K173593 · Fresenius Medical Care Renal Therapies Group, LLC · May 2018
Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set
K173651 · Fresenius Medical Care Renal Therapies Group, LLC · Feb 2018