Cleared Traditional

K951311 - GAMBRO HC 14R HEMOCONCENTRATOR

K951311 is an FDA 510(k) clearance for GAMBRO HC 14R HEMOCONCENTRATOR, 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 295-day FDA review.

K951311 · Cobe Renal Care, Inc. · Gastroenterology & Urology device
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Jan 1996
Decision
295d
Days
Class 2
Risk

K951311 is an FDA 510(k) clearance for the GAMBRO HC 14R HEMOCONCENTRATOR. 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 January 11, 1996 after a review of 295 days - an extended review cycle.

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 - K951311

510(k) Number K951311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1995
Decision Date January 11, 1996
Days to Decision 295 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
165d slower than avg
Panel avg: 130d · This submission: 295d
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 K951311.
DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE LUMEN OPTION
K955384 · Althin Medical AB an Affiliate of Baxter Intl · Jan 1997
MINNTECH MINNIFILTER PLUS HEMOFILTER AND TUBING SET
K962707 · Minntech Corp. · Oct 1996
ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM
K954987 · Althin Medical AB an Affiliate of Baxter Intl · Aug 1996
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