Cleared Traditional

K160847 - Rockwell Medical CitraPure Acid Concetrate

K160847 is an FDA 510(k) clearance for Rockwell Medical CitraPure Acid Concetrate, manufactured by Rockwell Medical. The device is a Class 2 Gastroenterology & Urology device with product code KPO cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K160847 · Rockwell Medical · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2016
Decision
206d
Days
Class 2
Risk

K160847 is an FDA 510(k) clearance for the Rockwell Medical CitraPure Acid Concetrate. Classified as Dialysate Concentrate For Hemodialysis (liquid Or Powder) (product code KPO), Class II - Special Controls.

Submitted by Rockwell Medical (Wixom, US). The FDA issued a Cleared decision on October 20, 2016 after a review of 206 days - an extended review 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: 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 Rockwell Medical devices

FDA 510(k) Submission Details - K160847

510(k) Number K160847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2016
Decision Date October 20, 2016
Days to Decision 206 days
Submission Type Traditional
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
75d slower than avg
Panel avg: 131d · This submission: 206d
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 82
Devices cleared under the same product code (KPO) and FDA review panel - the closest regulatory comparables to K160847.
Citryte
K171015 · Di-Chem, Inc. · Oct 2017
bibag
K162716 · Fresenius Medical Care Renal Therapies Group, LLC · May 2017
PrismaSATE
K162887 · Baxter Healthcare Corporation · Jan 2017
HMB32
K150966 · Haemopharm Biofluids S.R.L. · Dec 2015
MEDICALYTE(R) BICARBONATE POWDER (36.83X), MEDICALYTE(R) BICARBONATE POWDER (45X), MEDICALYTE(R) BICARBONATE POWDER (35X
K131202 · Dialysis Medical Solutions, LLC · Apr 2014
CITRISOL ACID CONCENTRATE
K130511 · Diasol, Inc. · Feb 2014