Cleared Traditional

K903869 - 90/2 PERITONEAL DIALYSIS SYSTEM DISPOS ...

K903869 is an FDA 510(k) clearance for 90/2 PERITONEAL DIALYSIS SYSTEM DISPOS ..., manufactured by Fresenius/Delmed, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KDJ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K903869 · Fresenius/Delmed, Inc. · Gastroenterology & Urology device
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Nov 1990
Decision
90d
Days
Class 2
Risk

K903869 is an FDA 510(k) clearance for the 90/2 PERITONEAL DIALYSIS SYSTEM DISPOS CYCLER SET. Classified as Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ), Class II - Special Controls.

Submitted by Fresenius/Delmed, Inc. (Concord, US). The FDA issued a Cleared decision on November 20, 1990 after a review of 90 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Fresenius/Delmed, Inc. devices

FDA 510(k) Submission Details - K903869

510(k) Number K903869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1990
Decision Date November 20, 1990
Days to Decision 90 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
40d faster than avg
Panel avg: 130d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDJ Device Classification - Class 2, Special Controls

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 94
Devices cleared under the same product code (KDJ) and FDA review panel - the closest regulatory comparables to K903869.
FRESENIUS SAFE-CONNECT CAPD MANUAL ASSIST DEVICE
K912208 · Fresenius USA, Inc. · Jul 1991
CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR
K904806 · Fresenius USA, Inc. · Jan 1991
CAPD DISPOSABLE DISCONNECT Y-SET CODE: 5C4481
K902526 · Baxter Healthcare Corp · Nov 1990
LONG-LIFE Y-SET CAT. NO. 48-6366-8
K902451 · National Medical Care, Medical Products Div., Inc. · Aug 1990
CLOSED DISCONNECT SYSTEM
K900106 · Delmed, Inc. · Jul 1990
DEXTROLYTE II CAPD TRANSFER SET - NO. 48-4009-6
K895792 · National Medical Care, Medical Products Div., Inc. · Mar 1990