510(k) · Cleared
ClearedHMB32 Dialysis Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Haemopharm Biofluids S.R.L. · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Cleared on Jul 23, 2021 as substantially equivalent to K150966 (Haemopharm Biofluids S.R.L., 2015) after a 23-day review. Its family tree reaches back 4 generations to 1987.
- Decided
- Jul 23, 2021
- Review
- 23 days
- Class
- Class II
- Product code
- KPO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K864265 (1987). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK864265 Hemodialysis Bath Concentrate Solutions for HemodiDial Medical of Florida, Inc. · 1987
- 3 generations backK013448 PrismasateGambro Renal Products · 2002
- 2 generations backK041428 Accusol Dialysis SolutionBaxter Healthcare Corp · 2004
- 1 generation backK150966 HMB32Haemopharm Biofluids S.R.L. · 2015
- This deviceK212052 HMB32 Dialysis SolutionHaemopharm Biofluids S.R.L. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K864265 | Hemodialysis Bath Concentrate Solutions for Hemodi | Dial Medical of Florida, Inc. | 1987 | — |
| −3 | K013448 | Prismasate | Gambro Renal Products | 2002 | — |
| −2 | K041428 | Accusol Dialysis Solution | Baxter Healthcare Corp | 2004 | — |
| −1 | K150966 | HMB32 | Haemopharm Biofluids S.R.L. | 2015 | — |
| 0 (this device) | K212052 | HMB32 Dialysis Solution | Haemopharm Biofluids S.R.L. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KPO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KPO device
- #1 K233159 pureFLOW 402, pureFLOW 400, pureFLOW 406…score 14.5 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K150966 | HMB32Summary page 4…s Solution Regulation Number: 21 CFR 876.5820 Product Code: KPO Classification: Class II Predicate Device Haemofiltration and Dialysis Solutions (K150966) Device Description The HBiofluids HMB32 is a bicarbonate-based dialysis solution packaged in a ready to mix, sterile, non-pyrog… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 34 years and passes through 4 companies; a new generation was cleared every 11.3 years on median.
- None of the 8 ancestors has a recall.
How does its category compare?
All KPO devicesKPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder): FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · KPO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPO
112in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPO
6in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPO
95in 2025
MAUDE reports naming product code KPO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 5 | 5 |
| 2008 | 2 | — | 2 | 8 |
| 2009 | 1 | — | 1 | 3 |
| 2010 | 0 | — | 0 | 107 |
| 2011 | 1 | — | 2 | 223 |
| 2012 | 2 | — | 10 | 70 |
| 2013 | 1 | — | 0 | 3,897 |
| 2014 | 2 | — | 0 | 15,916 |
| 2015 | 1 | — | 3 | 8,340 |
| 2016 | 1 | — | 1 | 240 |
| 2017 | 3 | 192 | 1 | 80 |
| 2018 | 2 | — | 11 | 97 |
| 2019 | 0 | — | 1 | 79 |
| 2020 | 5 | 270 | 31 | 244 |
| 2021 | 1 | — | 0 | 63 |
| 2022 | 2 | — | 2 | 25 |
| 2023 | 3 | 263 | 0 | 59 |
| 2024 | 3 | 112 | 1 | 259 |
| 2025 | 2 | — | 6 | 95 |
| 2026 | 2 | — | 9 | — |
What is it indicated for?
Intended for use as a dialysis solution in Continuous Renal Replacement Therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212052 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212052: HMB32 Dialysis Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212052
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026