Cleared Traditional

K920586 - DEXTROLYTE II PERITONEAL DIALYSIS ADMIN. SET

K920586 is an FDA 510(k) clearance for DEXTROLYTE II PERITONEAL DIALYSIS ADMIN..., manufactured by National Medical Care, Medical Products Div., Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KDJ cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K920586 · National Medical Care, Medical Products Div., Inc. · Gastroenterology & Urology device
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Sep 1992
Decision
224d
Days
Class 2
Risk

K920586 is an FDA 510(k) clearance for the DEXTROLYTE II PERITONEAL DIALYSIS ADMIN. SET. Classified as Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ), Class II - Special Controls.

Submitted by National Medical Care, Medical Products Div., Inc. (Rockleigh, US). The FDA issued a Cleared decision on September 21, 1992 after a review of 224 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 National Medical Care, Medical Products Div., Inc. devices

FDA 510(k) Submission Details - K920586

510(k) Number K920586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1992
Decision Date September 21, 1992
Days to Decision 224 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 131d · This submission: 224d
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 100
Devices cleared under the same product code (KDJ) and FDA review panel - the closest regulatory comparables to K920586.
BAXTER APD 12' EXTENSION LINE
K925403 · Baxter Healthcare Corp · Feb 1994
FRESENIUS VARIABLE FILL MONITOR
K921052 · Fresenius USA, Inc. · Feb 1993
DEXTROLYTE II CAPD TRNSFER SET
K920029 · National Medical Care, Medical Products Div., Inc. · Sep 1992
DEXTROLYTE II PERITONEAL DIALYSIS PUMP
K915628 · National Medical Care, Medical Products Div., Inc. · Mar 1992
ABBOTT SMART CAP
K915304 · Abbott Laboratories · Feb 1992
FRESENIUS SAFE-CONNECT CAPD MANUAL ASSIST DEVICE
K912208 · Fresenius USA, Inc. · Jul 1991