510(k) · Cleared
ClearedDiasol-Bicarb
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diasol, Inc. · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Cleared on Apr 23, 2002 as substantially equivalent to K792213 (Renal Systems, Inc., 1980) and 2 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1978.
- Decided
- Apr 23, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- KPO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K781967 (1978). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK781967 Hemodialysis Concentrate, SodiuRenal Systems, Inc. · 1978
- This deviceK020230 Diasol-BicarbDiasol, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K781967 | Hemodialysis Concentrate, Sodiu | Renal Systems, Inc. | 1978 | — |
| 0 (this device) | K020230 | Diasol-Bicarb | Diasol, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1997 | 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? (3)
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 |
|---|---|---|---|
| * | K792213 | Renal Systems Hemodialysis ConcentrateSummary page 1…ATE FOR HEMODIALYSIS CLASSIFICATION NAME HEMODIALYSIS SYSTEMS AND ACCESSORIES CLASS II PERFORMANCE STANDARD NONE ESTABLISHED UNDER 514 OF FDA PREDICATE DEVICE RENOSOL K792213 and K781967 STERILYTE K971053 DEVICE DESCRIPTION: Sodium Bicarbonate is part of the dialysate concentrate for hemodialysis. Whe… | 1980 |
| * | K781967 | Hemodialysis Concentrate, SodiuSummary page 1…DIALYSIS CLASSIFICATION NAME HEMODIALYSIS SYSTEMS AND ACCESSORIES CLASS II PERFORMANCE STANDARD NONE ESTABLISHED UNDER 514 OF FDA PREDICATE DEVICE RENOSOL K792213 and K781967 STERILYTE K971053 DEVICE DESCRIPTION: Sodium Bicarbonate is part of the dialysate concentrate for hemodialysis. When mixed with… | 1978 |
| * | K971053 | Rockwell Medical Supply,LLC. Bicarbonate Solution Concentrates for Bicarbonate DialysisSummary page 1…CATION NAME HEMODIALYSIS SYSTEMS AND ACCESSORIES CLASS II PERFORMANCE STANDARD NONE ESTABLISHED UNDER 514 OF FDA PREDICATE DEVICE RENOSOL K792213 and K781967 STERILYTE K971053 DEVICE DESCRIPTION: Sodium Bicarbonate is part of the dialysate concentrate for hemodialysis. When mixed with AAMI standard wat… | 1997 |
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?
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K792213.
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.
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?
Diasol-BiCarb Solutions are indicated for use in acute and chronic hemodaalysis and have to be used in conjunction with Diasol acid concentrate or any other commercially available concentrate in the correct proportioning and AAMI standard water as Dialysate solution for hemnodialysis For use in 3 stream dialysis machines calibrated for use with acid and bicarbonate concentrate.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020230 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020230: Diasol-Bicarb.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020230
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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