510(k) · Cleared
ClearedModification to: Dryac Acid Concentrate Mix for Bicarbonate Hemodialysis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gambro Renal Products · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Cleared on Nov 2, 2005 as substantially equivalent to K011368 (Gambro Renal Products, 2001) after a 76-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Nov 2, 2005
- Review
- 76 days
- Class
- Class II
- Product code
- KPO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011368 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK011368 Dry AC Acid Concentrate Mix for Bicarbonate HemodialysisGambro Renal Products · 2001
- This deviceK052253 Modification to: Dryac Acid Concentrate Mix for Bicarbonate…Gambro Renal Products · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011368 | Dry AC Acid Concentrate Mix for Bicarbonate Hemodialysis | Gambro Renal Products | 2001 | — |
| 0 (this device) | K052253 | Modification to: Dryac Acid Concentrate Mix for Bicarbonate Hemodialysis | Gambro Renal Products | 2005 | — |
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 |
|---|---|---|---|
| * | K011368 | Dry AC Acid Concentrate Mix for Bicarbonate HemodialysisSummary page 1…Powder) Equivalent Predicate: DryAC Acid Concentrate Mix for Bicarbonate Dialysis Gamnbro Renal Products, K01 1368 Device Description: Gambro DryAC is an acid concentrate mix used for the preparation… | 2001 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K011368.
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?
Gambro DryAC acid concentrate mix for bicarbonate hemodialysis is indicated for use with concentrated bicarbonate solution in 3-stream proportioning artificial kidney equipment using purified, AAMI standard water.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052253 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052253: Modification to: Dryac Acid Concentrate Mix for Bicarbonate Hemodialysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052253
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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