Cleared Traditional

K900008 - DEXTROLYTE II

K900008 is the FDA 510(k) clearance for DEXTROLYTE II 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 79-day FDA review.

K900008 · National Medical Care, Medical Products Div., Inc. · Gastroenterology & Urology device
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Mar 1990
Decision
79d
Days
Class 2
Risk

K900008 is an FDA 510(k) clearance for the DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER 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 March 22, 1990 after a review of 79 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all National Medical Care, Medical Products Div., Inc. devices

Submission Details

510(k) Number K900008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1990
Decision Date March 22, 1990
Days to Decision 79 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 130d · This submission: 79d
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 K900008.
PERITONEAL DIALYSIS DRAINAGE SET NO. 48-0025-6
K895991 · National Medical Care, Medical Products Div., Inc. · Mar 1990
DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET -(8)
K896599 · National Medical Care, Medical Products Div., Inc. · Mar 1990
DEXTROLYTE II, SINGLE USE Y SET NO. 48-6360-1
K896600 · National Medical Care, Medical Products Div., Inc. · Mar 1990
DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET
K900012 · National Medical Care, Medical Products Div., Inc. · Mar 1990
DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET W/3
K900140 · National Medical Care, Medical Products Div., Inc. · Mar 1990
DEXTROLYTE II, W/5 PRONG MANIFOLD NO. 48-1100-6
K900141 · National Medical Care, Medical Products Div., Inc. · Mar 1990