Cleared Traditional

K050827 - NORMOCARD 25 (STERILE BICARBONATE RENAL...

K050827 is an FDA 510(k) clearance for NORMOCARD 25 (STERILE BICARBONATE RENAL..., manufactured by Dialysis Solutions, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KPO cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K050827 · Dialysis Solutions, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
143d
Days
Class 2
Risk

K050827 is an FDA 510(k) clearance for the NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE). Classified as Dialysate Concentrate For Hemodialysis (liquid Or Powder) (product code KPO), Class II - Special Controls.

Submitted by Dialysis Solutions, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on August 22, 2005 after a review of 143 days - within the typical 510(k) review window.

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 Dialysis Solutions, Inc. devices

FDA 510(k) Submission Details - K050827

510(k) Number K050827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2005
Decision Date August 22, 2005
Days to Decision 143 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 130d · This submission: 143d
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 K050827.
FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES
K070177 · Fresenius Medical Care North America · Mar 2007
MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION
K053286 · Nxstage Medical, Inc. · Dec 2005
B. BRAUN MODIFIED BICARBONATE DIALYSATE
K052393 · B.Braun Medical, Inc. · Nov 2005
ACCUSOL DIALYSIS SOLUTION
K041428 · Baxter Healthcare Corp · Aug 2004
B. BRAUN BICARBONATE DIALYSATE
K041683 · B.Braun Medical, Inc. · Aug 2004
NXSTAGE PUREFLOW-B SOLUTION
K042045 · Nxstage Medical, Inc. · Aug 2004