Cleared Traditional

K223431 - Citric Complete Liquid Citric Acid Conc...

K223431 is an FDA 510(k) clearance for Citric Complete Liquid Citric Acid Conc..., manufactured by Nipro Renal Solutions USA, Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KPO cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K223431 · Nipro Renal Solutions USA, Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
263d
Days
Class 2
Risk

K223431 is an FDA 510(k) clearance for the Citric Complete Liquid Citric Acid Concentrate. Classified as Dialysate Concentrate For Hemodialysis (liquid Or Powder) (product code KPO), Class II - Special Controls.

Submitted by Nipro Renal Solutions USA, Corp. (Lewisberry, US). The FDA issued a Cleared decision on August 4, 2023 after a review of 263 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 Nipro Renal Solutions USA, Corp. devices

FDA 510(k) Submission Details - K223431

510(k) Number K223431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2022
Decision Date August 04, 2023
Days to Decision 263 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
133d slower than avg
Panel avg: 130d · This submission: 263d
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 58
Devices cleared under the same product code (KPO) and FDA review panel - the closest regulatory comparables to K223431.
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
NIKKICART
K221652 · Renal Care Dialysis Solutions, S.A. DE C.V. · Mar 2023
Hemo-Lyte C Cartridge
K202508 · Di-Chem, Inc. · Aug 2022
Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate
K212620 · Fresenius Medical Care Renal Therapies Group, LLC · May 2022