Cleared Traditional

Citric Complete Liquid Citric Acid Concentrate (K223431) - FDA 510(k) Clearance

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

K223431 · Nipro Renal Solutions USA, Corp. · Gastroenterology & Urology device
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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

Submission Details

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.

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 28
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