Cleared Traditional

K192209 - Citrasate Dry Acid Concentrate

K192209 is the FDA 510(k) clearance for Citrasate Dry Acid Concentrate by Fresenius Medical Care Renal Therapies Group, LLC. It is a Class 2 Gastroenterology & Urology device (product code KPO) cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K192209 · Fresenius Medical Care Renal Therapies Group, LLC · Gastroenterology & Urology device
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May 2020
Decision
268d
Days
Class 2
Risk

K192209 is an FDA 510(k) clearance for the Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate. Classified as Dialysate Concentrate For Hemodialysis (liquid Or Powder) (product code KPO), Class II - Special Controls.

Submitted by Fresenius Medical Care Renal Therapies Group, LLC (Waltham, US). The FDA issued a Cleared decision on May 8, 2020 after a review of 268 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 Fresenius Medical Care Renal Therapies Group, LLC devices

Submission Details

510(k) Number K192209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2019
Decision Date May 08, 2020
Days to Decision 268 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
138d slower than avg
Panel avg: 130d · This submission: 268d
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 49
Devices cleared under the same product code (KPO) and FDA review panel - the closest regulatory comparables to K192209.
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
Nipro Dry Complete Dry Acid Concentrate for Hemodialysis
K193155 · Nipro Renal Solutions USA, Corp. · Nov 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
Isopure Dry Acid Dissolution System
K191093 · Isopure, Corp. · Jan 2020