Cleared Special

K071387 - FRESENIUS NATURALYTE SODIUM BICARBONATE...

K071387 is the FDA 510(k) clearance for FRESENIUS NATURALYTE SODIUM BICARBONATE... by Fresenius Medical Care North America. It is a Class 2 Gastroenterology & Urology device (product code KPO) cleared through the Special 510(k) pathway after a 28-day FDA review.

K071387 · Fresenius Medical Care North America · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
28d
Days
Class 2
Risk

K071387 is an FDA 510(k) clearance for the FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB. Classified as Dialysate Concentrate For Hemodialysis (liquid Or Powder) (product code KPO), Class II - Special Controls.

Submitted by Fresenius Medical Care North America (Waltham, US). The FDA issued a Cleared decision on June 15, 2007 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Fresenius Medical Care North America devices

Submission Details

510(k) Number K071387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2007
Decision Date June 15, 2007
Days to Decision 28 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 130d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 50
Devices cleared under the same product code (KPO) and FDA review panel - the closest regulatory comparables to K071387.
PrismaSATE
K162887 · Baxter Healthcare Corporation · Jan 2017
FRESENIUS DRY ACID DISSOLUTION UNITS
K131611 · Fresenius Medical Care North America · Aug 2013
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K090002 · Baxter Healthcare Corp · Aug 2009
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