510(k) · Cleared
ClearedAcid Concentrate 45X (2.0K, 3.1CA), Model 5M8001A, Acid Concentrate 45X (2.0K, 2.5CA), Model 5M8002A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Cleared on Aug 7, 2009 as substantially equivalent to K792213 (Renal Systems, Inc., 1980) and 2 other predicates after a 217-day review. Its family tree reaches back 1 generation to 1978.
- Decided
- Aug 7, 2009
- Review
- 217 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 deviceK090002 Acid Concentrate 45X (2.0K, 3.1CA), Model 5M8001A, Acid Concentrate…Baxter Healthcare Corp · 2009
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) | K090002 | Acid Concentrate 45X (2.0K, 3.1CA), Model 5M8001A, Acid Concentrate 45X (2.0K… | Baxter Healthcare Corp | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1996 | 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 2…Previous 510(k)s Device Company Previous 510(k) Clearance Date Renal Systems Renal Systems, Inc. K792213 01/04/1980 Hemodialysis Concentrate Renal Systems Renal Systems, Inc. K781967 1… | 1980 |
| * | K781967 | Hemodialysis Concentrate, SodiuSummary page 2…l Systems Renal Systems, Inc. K792213 01/04/1980 Hemodialysis Concentrate Renal Systems Renal Systems, Inc. K781967 12/07/1978 Hemodialysis Concentrate Rockwell Medical Rockwell Medical K954527 0… | 1978 |
| * | K954527 | Rockwell Medical Supply LLC Hemodialysis Concentrate Solutions & PowdersSummary page 2…Systems Renal Systems, Inc. K781967 12/07/1978 Hemodialysis Concentrate Rockwell Medical Rockwell Medical K954527 03/01/1996 Supply LLC, Supply LLC Hemodialysis Concentrate DEVICE DESCRIPTION: Baxter's Acid Conc… | 1996 |
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?
- 1 of the 3 ancestors has a recall of any class.
- 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. 2009, 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?
Acid Concentrate is indicated for use as acid concentrate in hemodialysis therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090002 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090002: Acid Concentrate 45X (2.0K, 3.1CA), Model 5M8001A, Acid Concentrate 45X (2.0K, 2.5CA), Model 5M8002A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090002
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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