Cleared Traditional

K915628 - DEXTROLYTE II PERITONEAL DIALYSIS PUMP

K915628 is the FDA 510(k) clearance for DEXTROLYTE II PERITONEAL DIALYSIS PUMP by National Medical Care, Medical Products Div., Inc.. It is a Class 2 Gastroenterology & Urology device (product code KDJ) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K915628 · National Medical Care, Medical Products Div., Inc. · Gastroenterology & Urology device
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Mar 1992
Decision
90d
Days
Class 2
Risk

K915628 is an FDA 510(k) clearance for the DEXTROLYTE II PERITONEAL DIALYSIS PUMP. 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 March 16, 1992 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 National Medical Care, Medical Products Div., Inc. devices

Submission Details

510(k) Number K915628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1991
Decision Date March 16, 1992
Days to Decision 90 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
40d faster than avg
Panel avg: 130d · This submission: 90d
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 78
Devices cleared under the same product code (KDJ) and FDA review panel - the closest regulatory comparables to K915628.
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 ADMIN. SET
K920586 · National Medical Care, Medical Products Div., Inc. · Sep 1992
ABBOTT SMART CAP
K915304 · Abbott Laboratories · Feb 1992
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