510(k) · Cleared
Recalled · Class II · 2018Rockwell Medical Supply, LLC. Dri-Sate Acid Concentrate Mixes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Medical Products, Inc. · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Cleared on Jun 16, 1998 after a 90-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Jun 16, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- KPO
- Recalls
- 3
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK981003 Rockwell Medical Supply, LLC. Dri-Sate Acid Concentrate MixesInternational Medical Products, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK022500 Dri-Sate Dry Acid Concentrate for Bicarbonate DialysateRockwell Medical Technologies, Inc. · 2002
Most influential descendants
Showing 1 of 1 · See all- K022500Dri-Sate Dry Acid Concentrate for Bicarbonate DialysateRockwell Medical Technologies, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981003 | Rockwell Medical Supply, LLC. Dri-Sate Acid Concentrate Mixes | International Medical Products, Inc. | 1998 | — |
| +1 | K022500 | Dri-Sate Dry Acid Concentrate for Bicarbonate Dialysate | Rockwell Medical Technologies, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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? (2)
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 |
|---|---|---|---|
| * | — | Renal Systems Sta-Pak Bicarbonate Hemodialysis Bath Concentrate Solutions & Powders Named without a submission number | |
| * | — | Dial Medical, Inc. Acetate-Based Concentrate Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022500 | Dri-Sate Dry Acid Concentrate for Bicarbonate Dialysate | 2002 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 7, 2018 | Class II | Z-1869-2018 | Employee error | A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch. |
| Dec 3, 2007 | Not classified | Z-0875-2008 | Process control | Foil Seal Deterioration; occuring on the tamper resistant foil seals on dialysis liquid concentrate and Dri-Sate product containers older than two years old. |
| Dec 3, 2007 | Not classified | Z-0874-2008 | Process control | Foil Seal Deterioration; occuring on the tamper resistant foil seals on dialysis liquid concentrate and Dri-Sate product containers older than two years old. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K022500 (Rockwell Medical Technologies, Inc., 2002) has gone furthest, with 0 descendants of its own.
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?
The Rockwell Medical Supply LLC. Dri-Sate Acid Concentrate Solutions and powders for
Bicarbonate Dialysate are indicated for use in acute and chronic hemodialysis and to be
used with the appropriate hemodialysis machine/ monitor 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/K981003 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981003: Rockwell Medical Supply, LLC. Dri-Sate Acid Concentrate Mixes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981003
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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