510(k) · Cleared
ClearedNaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Medical Care Renal Therapies Group, LLC · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Cleared on Jan 29, 2026 as substantially equivalent to K191474 (Fresenius Medical Care Renal Therapies Group, LLC, 2020) after a 114-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Jan 29, 2026
- Review
- 114 days
- Class
- Class II
- Product code
- KPO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K981043 (1998). No later device cites it as a predicate yet.
- Root · 2 generations backK981043 Dialysol-Acid Concentrate Liquid, Granusol-Acid Concentrate Powder…Solution Technologies · 1998 · Recalled
- 1 generation backK191474 NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry…Fresenius Medical Care Renal Therapies Group, LLC · 2020 · Recalled
- This deviceK253462 NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)Fresenius Medical Care Renal Therapies Group, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K981043 | Dialysol-Acid Concentrate Liquid, Granusol-Acid Concentrate Powder… | Solution Technologies | 1998 | 1 |
| −1 | K191474 | NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate… | Fresenius Medical Care Renal Therapies Group, LLC | 2020 | 1 |
| 0 (this device) | K253462 | NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) | Fresenius Medical Care Renal Therapies Group, LLC | 2026 | — |
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 |
|---|---|---|---|
| * | K191474 | NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate…Summary page 5…astroenterology/Urology 1.3. Legally Marketed Predicate Device The legally marketed predicate device is the NaturaLyte® Dry Bicarbonate Concentrate (08- 4112-2) (K191474). This predicate has not been subject to a design-related recall. 1.4. Device Description 1.4.1. Device Identificati… | 2020 |
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 28 years and passes through 2 companies; a new generation was cleared every 21.7 years on median.
- 2 of the 2 ancestors have a recall of any class.
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. 2026, 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?
NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) is intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician’s prescription.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253462 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253462: NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253462
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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