Cleared Traditional

K900106 - CLOSED DISCONNECT SYSTEM

K900106 is the FDA 510(k) clearance for CLOSED DISCONNECT SYSTEM by Delmed, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KDJ) cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K900106 · Delmed, Inc. · Gastroenterology & Urology device
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Jul 1990
Decision
188d
Days
Class 2
Risk

K900106 is an FDA 510(k) clearance for the CLOSED DISCONNECT SYSTEM. Classified as Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ), Class II - Special Controls.

Submitted by Delmed, Inc. (New Brunswick, US). The FDA issued a Cleared decision on July 16, 1990 after a review of 188 days - an extended review cycle.

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 Delmed, Inc. devices

Submission Details

510(k) Number K900106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1990
Decision Date July 16, 1990
Days to Decision 188 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
58d slower than avg
Panel avg: 130d · This submission: 188d
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 41
Devices cleared under the same product code (KDJ) and FDA review panel - the closest regulatory comparables to K900106.
BAXTER APD 12' EXTENSION LINE
K925403 · Baxter Healthcare Corp · Feb 1994
ABBOTT SMART CAP
K915304 · Abbott Laboratories · Feb 1992
CAPD DISPOSABLE DISCONNECT Y-SET CODE: 5C4481
K902526 · Baxter Healthcare Corp · Nov 1990
DISCONNECT CAPS PRODUCT CODES 5C4212 AND 5C4466
K895631 · Baxter Healthcare Corp · Jan 1990
CONNECTION SHIELDS CODES 5C4213 AND 5C4215
K895673 · Baxter Healthcare Corp · Jan 1990
PERITONEAL DIAL. TITA. CATH ADAPTER & LOCKING CAP
K894783 · Baxter Healthcare Corp · Sep 1989