Cleared Traditional

K030497 - FRESENIUS NATURALYTE GRANUFLO DRY ACID ...

K030497 is an FDA 510(k) clearance for FRESENIUS NATURALYTE GRANUFLO DRY ACID ..., manufactured by Fresenius Medical Care. The device is a Class 2 Gastroenterology & Urology device with product code KPO cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K030497 · Fresenius Medical Care · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
90d
Days
Class 2
Risk

K030497 is an FDA 510(k) clearance for the FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, .... Classified as Dialysate Concentrate For Hemodialysis (liquid Or Powder) (product code KPO), Class II - Special Controls.

Submitted by Fresenius Medical Care (Lexington, US). The FDA issued a Cleared decision on May 20, 2003 after a review of 90 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 Fresenius Medical Care devices

FDA 510(k) Submission Details - K030497

510(k) Number K030497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2003
Decision Date May 20, 2003
Days to Decision 90 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
40d faster than avg
Panel avg: 130d · This submission: 90d
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 60
Devices cleared under the same product code (KPO) and FDA review panel - the closest regulatory comparables to K030497.
NXSTAGE PUREFLOW-B SOLUTION
K042045 · Nxstage Medical, Inc. · Aug 2004
B.BRAUN PREMIXED DIALYSATE
K034066 · B.Braun Medical, Inc. · Mar 2004
NXSTAGE PUREFLOW SOLUTION
K033386 · Nxstage Medical, Inc. · Nov 2003
NXSTAGE PREMIXED DIALYSATE
K022913 · Nxstage Medical, Inc. · Oct 2002
NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100
K013655 · Nxstage Medical, Inc. · Feb 2002
PRISMASATE
K013448 · Gambro Renal Products · Jan 2002