Cleared Traditional

K001059 - NORMOCARB STERILE BICARBONATE RENAL DIALYSIS

K001059 is an FDA 510(k) clearance for NORMOCARB STERILE BICARBONATE RENAL DIA..., manufactured by Novex Pharma. The device is a Class 2 Gastroenterology & Urology device with product code KPO cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K001059 · Novex Pharma · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
88d
Days
Class 2
Risk

K001059 is an FDA 510(k) clearance for the NORMOCARB STERILE BICARBONATE RENAL DIALYSIS. Classified as Dialysate Concentrate For Hemodialysis (liquid Or Powder) (product code KPO), Class II - Special Controls.

Submitted by Novex Pharma (Richmond Hill, Ontario, CA). The FDA issued a Cleared decision on June 30, 2000 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Novex Pharma devices

FDA 510(k) Submission Details - K001059

510(k) Number K001059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2000
Decision Date June 30, 2000
Days to Decision 88 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
43d faster than avg
Panel avg: 131d · This submission: 88d
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 93
Devices cleared under the same product code (KPO) and FDA review panel - the closest regulatory comparables to K001059.
BICART
K013724 · Gambro Renal Products · Jan 2002
DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS
K011368 · Gambro Renal Products · Aug 2001
ART BICARBONATE FOR HEMODIALYSIS, ART BICARBONATE LIQUID FOR HEMODIALYSIS
K010760 · Advanced Renal Technologies, Inc. · Jun 2001
CITRASATE DIALYSATE ACID CONCENTRATE LIQUID, MODELS CS-1XXX-XX, CS-XXX-XX, CS-3XXX-XX
K000792 · Advanced Renal Technologies, Inc. · Jun 2000
DRYASOL ACID CONCENTRATE MIX
K993212 · Diasol, Inc. · Oct 1999
DRI-SATE MIXER FOR PREPARATION OF ACIDIFIED DIALYSATE CONCENTRATE
K983618 · Rockwell Medical Technologies, Inc. · Aug 1999