Cleared Traditional

NIKKICART (K221652) - FDA 510(k) Clearance

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

K221652 · Renal Care Dialysis Solutions, S.A. DE C.V. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2023
Decision
269d
Days
Class 2
Risk

K221652 is an FDA 510(k) clearance for the NIKKICART. Classified as Dialysate Concentrate For Hemodialysis (liquid Or Powder) (product code KPO), Class II - Special Controls.

Submitted by Renal Care Dialysis Solutions, S.A. DE C.V. (El Marques, MX). The FDA issued a Cleared decision on March 3, 2023 after a review of 269 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 Renal Care Dialysis Solutions, S.A. DE C.V. devices

Submission Details

510(k) Number K221652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2022
Decision Date March 03, 2023
Days to Decision 269 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
139d slower than avg
Panel avg: 130d · This submission: 269d
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 Consultant

Namsa
Brittany Valdez Nava

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K221652.
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
Citric Complete Liquid Citric Acid Concentrate
K223431 · Nipro Renal Solutions USA, Corp. · Aug 2023
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K202508 · Di-Chem, Inc. · Aug 2022
Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate
K212620 · Fresenius Medical Care Renal Therapies Group, LLC · May 2022
HMB32 Dialysis Solution
K212052 · Haemopharm Biofluids S.R.L. · Jul 2021