Cleared Traditional

Nipro Dry Complete Dry Acid Concentrate for Hemodialysis (K193155) - FDA 510(k) Clearance

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

K193155 · Nipro Renal Solutions USA, Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2020
Decision
377d
Days
Class 2
Risk

K193155 is an FDA 510(k) clearance for the Nipro Dry Complete Dry Acid Concentrate for Hemodialysis. 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 November 25, 2020 after a review of 377 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K193155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2019
Decision Date November 25, 2020
Days to Decision 377 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
247d slower than avg
Panel avg: 130d · This submission: 377d
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

Mcnees Wallace & Nurick, LLC
David M Marcus

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 K193155.
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
HMB32 Dialysis Solution
K212052 · Haemopharm Biofluids S.R.L. · Jul 2021
Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate
K192209 · Fresenius Medical Care Renal Therapies Group, LLC · May 2020
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