Cleared Traditional

K952342 - GAMBRO LUNDIA 94-700 & SIGMA 800 HEMODI...

K952342 is an FDA 510(k) clearance for GAMBRO LUNDIA 94-700 & SIGMA 800 HEMODI..., manufactured by Cobe Renal Care, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K952342 · Cobe Renal Care, Inc. · Gastroenterology & Urology device
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Sep 1995
Decision
119d
Days
Class 2
Risk

K952342 is an FDA 510(k) clearance for the GAMBRO LUNDIA 94-700 & SIGMA 800 HEMODIALYZERS. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Cobe Renal Care, Inc. (Lakewood, US). The FDA issued a Cleared decision on September 15, 1995 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5860 - 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 Cobe Renal Care, Inc. devices

FDA 510(k) Submission Details - K952342

510(k) Number K952342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1995
Decision Date September 15, 1995
Days to Decision 119 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
11d faster than avg
Panel avg: 130d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDI Device Classification - Class 2, Special Controls

Product Code KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5860
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 - KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

All 217
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K952342.
ALTRA FLUX 110 HEMODIALYZER
K952978 · Althin Medical AB an Affiliate of Baxter Intl · Oct 1995
ALTREX 110 HEMODIALYZER
K952982 · Althin Medical AB an Affiliate of Baxter Intl · Oct 1995
ALTR NOVA 110 HEMODIALYZER
K952983 · Althin Medical AB an Affiliate of Baxter Intl · Oct 1995
RMI HEMOCONCENTRATOR
K951344 · Research Medical, Inc. · Aug 1995
ALTRA NOVA(TM) 170 HEMODIALYZER
K945621 · Althin Medical AB an Affiliate of Baxter Intl · May 1995
ALTRA NOVA(TM) 140 HEMODIALYZER
K945625 · Althin Medical AB an Affiliate of Baxter Intl · May 1995