Cleared Traditional

K180679 - 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 is an FDA 510(k) clearance for CitriCon Liquid and Powder (Acid Concen..., manufactured by Global Scientific Technologies, LLC. The device is a Class 2 Gastroenterology & Urology device with product code KPO cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K180679 · Global Scientific Technologies, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2018
Decision
267d
Days
Class 2
Risk

K180679 is an FDA 510(k) clearance for the CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), Ace.... Classified as Dialysate Concentrate For Hemodialysis (liquid Or Powder) (product code KPO), Class II - Special Controls.

Submitted by Global Scientific Technologies, LLC (Greer, US). The FDA issued a Cleared decision on December 7, 2018 after a review of 267 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 Global Scientific Technologies, LLC devices

FDA 510(k) Submission Details - K180679

510(k) Number K180679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2018
Decision Date December 07, 2018
Days to Decision 267 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
136d slower than avg
Panel avg: 131d · This submission: 267d
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 79
Devices cleared under the same product code (KPO) and FDA review panel - the closest regulatory comparables to K180679.
Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate
K192017 · Fresenius Medical Care Renal Therapies Group, LLC · Apr 2020
NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton)
K191474 · Fresenius Medical Care Renal Therapies Group, LLC · Feb 2020
Isopure Dry Acid Dissolution System
K191093 · Isopure, Corp. · Jan 2020
Citric Complete Dry Citric Acid (45X)
K171750 · Dimesol USA, LLC · Mar 2018
Citryte
K171015 · Di-Chem, Inc. · Oct 2017
bibag
K162716 · Fresenius Medical Care Renal Therapies Group, LLC · May 2017