Cleared Traditional

K920693 - DEXTROLYTE II PERITONEAL DIALYSIS 48-30...

K920693 is the FDA 510(k) clearance for DEXTROLYTE II PERITONEAL DIALYSIS 48-30... by National Medical Care, Medical Products Div., Inc.. It is a Class 2 Gastroenterology & Urology device (product code FJG) cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K920693 · National Medical Care, Medical Products Div., Inc. · Gastroenterology & Urology device
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Sep 1992
Decision
220d
Days
Class 2
Risk

K920693 is an FDA 510(k) clearance for the DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9. Classified as Dialyzer, Parallel Flow (product code FJG), 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 876.5820 - 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 K920693 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
Combination Product No
PCCP Authorized No
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 FJG Dialyzer, Parallel Flow
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 - FJG Dialyzer, Parallel Flow

All 23
Devices cleared under the same product code (FJG) and FDA review panel - the closest regulatory comparables to K920693.
TENCKHOFF PERITONEAL DIALYSIS KIT
K902203 · Akcess Medical Products, Inc. · Aug 1990
GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N
K862840 · Gambro, Inc. · Sep 1986
GAMBRO LUNDIA PRO 3 & 5 DIALYZER
K853406 · Gambro, Inc. · Jan 1986
COBE PPD 1.3L, #18-520-009
K820694 · Cobe Laboratories, Inc. · Mar 1982
COBE PPD 1.9
K812336 · Cobe Laboratories, Inc. · Aug 1981
EXP 200 PARALLEL PLATE DIALYZER
K811439 · Extracorporeal Medical Specialities, Inc. · Jun 1981