Cleared Traditional

K920693 - DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9

K920693 is an FDA 510(k) clearance for DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9, manufactured by National Medical Care, Medical Products Div., Inc.. The device is a Class 2 Gastroenterology & Urology device with 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.

FDA 510(k) Submission Details - K920693

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
89d slower than avg
Panel avg: 131d · This submission: 220d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FJG Device Classification - Class 2, Special Controls

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 35
Devices cleared under the same product code (FJG) and FDA review panel - the closest regulatory comparables to K920693.
GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS
K933681 · Cobe Renal Care, Inc. · Sep 1994
GAMBRO LUNDIA PRO 200 DIALYZER
K933680 · Cobe Renal Care, Inc. · Aug 1994
GAMBRO LUNDIA ALPHA HEMODIALYZERS
K915504 · C.G.H. Medical, Inc. · Mar 1992
HEMOSPAL KITS A1, A2D, AO, & A1D
K901368 · Gambro-Hospal, Inc. · Aug 1990
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
K920693 · DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9
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