Cleared Traditional

K171015 - Citryte

K171015 is an FDA 510(k) clearance for Citryte, manufactured by Di-Chem, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KPO cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K171015 · Di-Chem, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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Oct 2017
Decision
192d
Days
Class 2
Risk

K171015 is an FDA 510(k) clearance for the Citryte. Classified as Dialysate Concentrate For Hemodialysis (liquid Or Powder) (product code KPO), Class II - Special Controls.

Submitted by Di-Chem, Inc. (Champlin, US). The FDA issued a Cleared decision on October 13, 2017 after a review of 192 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 Di-Chem, Inc. devices

FDA 510(k) Submission Details - K171015

510(k) Number K171015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2017
Decision Date October 13, 2017
Days to Decision 192 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
62d slower than avg
Panel avg: 130d · This submission: 192d
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 59
Devices cleared under the same product code (KPO) and FDA review panel - the closest regulatory comparables to K171015.
Isopure Dry Acid Dissolution System
K191093 · Isopure, Corp. · Jan 2020
CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon Liquid and Powder (Acid Concentrate acidified with Acetic Acid or Na Di Acetate), BicarboCon Liquid and Powder (Bicarb Concentrate), RenaCon Liquid and Powder (Acetate Concentrate with Na Acetate)
K180679 · Global Scientific Technologies, LLC · Dec 2018
Citric Complete Dry Citric Acid (45X)
K171750 · Dimesol USA, LLC · Mar 2018
bibag
K162716 · Fresenius Medical Care Renal Therapies Group, LLC · May 2017
PrismaSATE
K162887 · Baxter Healthcare Corporation · Jan 2017
FRESENIUS DRY ACID DISSOLUTION UNITS
K131611 · Fresenius Medical Care North America · Aug 2013