Cleared Traditional

K233213 - NxStage PureFlow Solution (FDA 510(k) Clearance)

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

K233213 · Nxstage Medical, Inc. · Gastroenterology & Urology device
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Jan 2024
Decision
112d
Days
Class 2
Risk

K233213 is an FDA 510(k) clearance for the NxStage PureFlow Solution. Classified as Dialysate Concentrate For Hemodialysis (liquid Or Powder) (product code KPO), Class II - Special Controls.

Submitted by Nxstage Medical, Inc. (Lawrence, US). The FDA issued a Cleared decision on January 18, 2024 after a review of 112 days - within the typical 510(k) review window.

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 Nxstage Medical, Inc. devices

Submission Details

510(k) Number K233213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2023
Decision Date January 18, 2024
Days to Decision 112 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
18d faster than avg
Panel avg: 130d · This submission: 112d
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 122
Devices cleared under the same product code (KPO) and FDA review panel - the closest regulatory comparables to K233213.
NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)
K253462 · Fresenius Medical Care Renal Therapies Group, LLC · Jan 2026
Bicarby Dialysate RFP-404 (RFP-404-W)
K252180 · Fresenius Medical Care Renal Therapies Group, LLC · Sep 2025
Bicarby Dialysate RFP-402 (RFP-402-G)
K243786 · Fresenius Medical Care Renal Therapies Group, LLC · Apr 2025
HemoCare Bicarbonate Concentrate Set (BCS)
K240920 · Deka Research and Development · Jul 2024
pureFLOW 402 (F00012067)
K233950 · Fresenius Medical Care Renal Therapies Group, LLC · May 2024
pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504
K233159 · Fresenius Medical Care Renal Therapies Group, LLC · Dec 2023