Cleared Traditional

K895990 - DEXTROLYTE II PERITONEAL DIALYSIS CYCLER SET

K895990 is an FDA 510(k) clearance for DEXTROLYTE II PERITONEAL DIALYSIS CYCLE..., 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 160-day FDA review.

K895990 · National Medical Care, Medical Products Div., Inc. · Gastroenterology & Urology device
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Mar 1990
Decision
160d
Days
Class 2
Risk

K895990 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 160 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 - K895990

510(k) Number K895990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1989
Decision Date March 22, 1990
Days to Decision 160 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
29d slower than avg
Panel avg: 131d · This submission: 160d
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 K895990.
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
CATHETER EXTENSION SET CAT. NO. 48-3027-9
K895992 · National Medical Care, Medical Products Div., Inc. · Mar 1990
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