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) (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K180679 · Global Scientific Technologies, LLC · Gastroenterology & Urology device
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.

Submission Details

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
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 156d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 7
Devices cleared under the same product code (KPO) and FDA review panel - the closest regulatory comparables to K180679.
NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)
K253462 · Fresenius Medical Care Renal Therapies Group, LLC · Jan 2026
Bicarby Dialysate RFP-404 (RFP-404-W)
K252180 · Fresenius Medical Care Renal Therapies Group, LLC · Sep 2025
Bicarby Dialysate RFP-402 (RFP-402-G)
K243786 · Fresenius Medical Care Renal Therapies Group, LLC · Apr 2025
pureFLOW 402 (F00012067)
K233950 · Fresenius Medical Care Renal Therapies Group, LLC · May 2024
NxStage PureFlow Solution
K233213 · Nxstage Medical, Inc. · Jan 2024
pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504
K233159 · Fresenius Medical Care Renal Therapies Group, LLC · Dec 2023