Cleared Traditional

DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP (K920697) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K920697 · National Medical Care, Medical Products Div., Inc. · Gastroenterology & Urology device
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Sep 1992
Decision
220d
Days
Class 2
Risk

K920697 is an FDA 510(k) clearance for the DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP. Classified as Dialyzer, Disposable (product code FJH), 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 220 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5830 - 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 K920697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1992
Decision Date September 21, 1992
Days to Decision 220 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 130d · This submission: 220d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FJH Dialyzer, Disposable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5830
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.