Cleared Special

K212052 - HMB32 Dialysis Solution (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K212052 · Haemopharm Biofluids S.R.L. · Gastroenterology & Urology device
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Jul 2021
Decision
23d
Days
Class 2
Risk

K212052 is an FDA 510(k) clearance for the HMB32 Dialysis Solution. Classified as Dialysate Concentrate For Hemodialysis (liquid Or Powder) (product code KPO), Class II - Special Controls.

Submitted by Haemopharm Biofluids S.R.L. (Tovo Di S. Agata, IT). The FDA issued a Cleared decision on July 23, 2021 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Haemopharm Biofluids S.R.L. devices

Submission Details

510(k) Number K212052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2021
Decision Date July 23, 2021
Days to Decision 23 days
Submission Type Special
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
107d faster than avg
Panel avg: 130d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

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 K212052.
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
NxStage PureFlow Solution
K233213 · Nxstage Medical, Inc. · Jan 2024