Cleared Special

K070177 - FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES

K070177 is an FDA 510(k) clearance for FRESENIUS NATURALYTE LIQUID ACID CONCEN..., manufactured by Fresenius Medical Care North America. The device is a Class 2 Gastroenterology & Urology device with product code KPO cleared through the Special 510(k) pathway after a 70-day FDA review.

K070177 · Fresenius Medical Care North America · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
70d
Days
Class 2
Risk

K070177 is an FDA 510(k) clearance for the FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES. 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 March 29, 2007 after a review of 70 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

FDA 510(k) Submission Details - K070177

510(k) Number K070177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2007
Decision Date March 29, 2007
Days to Decision 70 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
61d faster than avg
Panel avg: 131d · This submission: 70d
Pathway characteristics
Modification to existing cleared device.

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 79
Devices cleared under the same product code (KPO) and FDA review panel - the closest regulatory comparables to K070177.
ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A
K090002 · Baxter Healthcare Corp · Aug 2009
PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY
K072908 · Gambro Renal Products · Feb 2008
FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB
K071387 · Fresenius Medical Care North America · Jun 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
MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS
K052253 · Gambro Renal Products · Nov 2005