Cleared Traditional

K941958 - WESTERN DIALYSIS HEMODIALYSIS CONCENTRATE

K941958 is an FDA 510(k) clearance for WESTERN DIALYSIS HEMODIALYSIS CONCENTRATE, manufactured by Western Dialysis Supplies , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code KPO cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K941958 · Western Dialysis Supplies , Ltd. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Sep 1994
Decision
161d
Days
Class 2
Risk

K941958 is an FDA 510(k) clearance for the WESTERN DIALYSIS HEMODIALYSIS CONCENTRATE. Classified as Dialysate Concentrate For Hemodialysis (liquid Or Powder) (product code KPO), Class II - Special Controls.

Submitted by Western Dialysis Supplies , Ltd. (Calgary, Alberta, CA). The FDA issued a Cleared decision on September 30, 1994 after a review of 161 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 Western Dialysis Supplies , Ltd. devices

FDA 510(k) Submission Details - K941958

510(k) Number K941958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1994
Decision Date September 30, 1994
Days to Decision 161 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
31d slower than avg
Panel avg: 130d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPO Device Classification - Class 2, Special Controls

Product Code KPO Dialysate Concentrate For Hemodialysis (liquid Or Powder)
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 - KPO Dialysate Concentrate For Hemodialysis (liquid Or Powder)

All 53
Devices cleared under the same product code (KPO) and FDA review panel - the closest regulatory comparables to K941958.
NXSTAGE PREMIXED DIALYSATE
K022913 · Nxstage Medical, Inc. · Oct 2002
NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100
K013655 · Nxstage Medical, Inc. · Feb 2002
FRESENIUS DIALYSATE ACID CONCENTRATE
K922088 · Fresenius USA, Inc. · Oct 1994
HEMODIALYSIS BATH
K922990 · Medi-Tech, Inc. · Sep 1994
GRANULYTE DIALYSATE CONCENTRATE
K922005 · Fresenius USA, Inc. · Mar 1994
GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXING
K911459 · Fresenius USA, Inc. · Jul 1991