Cleared Traditional

K130511 - CITRISOL ACID CONCENTRATE

K130511 is an FDA 510(k) clearance for CITRISOL ACID CONCENTRATE, manufactured by Diasol, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KPO cleared through the Traditional 510(k) pathway after a 348-day FDA review.

K130511 · Diasol, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Feb 2014
Decision
348d
Days
Class 2
Risk

K130511 is an FDA 510(k) clearance for the CITRISOL ACID CONCENTRATE. Classified as Dialysate Concentrate For Hemodialysis (liquid Or Powder) (product code KPO), Class II - Special Controls.

Submitted by Diasol, Inc. (San Fernando, US). The FDA issued a Cleared decision on February 10, 2014 after a review of 348 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Diasol, Inc. devices

FDA 510(k) Submission Details - K130511

510(k) Number K130511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2013
Decision Date February 10, 2014
Days to Decision 348 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
217d slower than avg
Panel avg: 131d · This submission: 348d
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 K130511.
Rockwell Medical CitraPure Acid Concetrate
K160847 · Rockwell Medical · Oct 2016
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
FRESENIUS DRY ACID DISSOLUTION UNITS
K131611 · Fresenius Medical Care North America · Aug 2013
PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY
K120333 · Gambro Renal Products · May 2012
ACDS
K120005 · Isopure, Corp. · Mar 2012