510(k) · Cleared
Recalled · Class I · 2015Fresenius Naturalyte Sodium Bicarbonate Liquid Concentrate, Model 08-4000-LB
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Medical Care North America · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Cleared on Jun 15, 2007 as substantially equivalent to K981043 (Solution Technologies, 1998) after a 28-day review. Its family tree reaches back 1 generation to 1998. 1 of the 2 devices in its family, counting itself, has a Class I recall. It has been recalled 6 times, including a Class I recall.
- Decided
- Jun 15, 2007
- Review
- 28 days
- Class
- Class II
- Product code
- KPO
- Recalls
- 6 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 1 generation to K981043 (1998). No later device cites it as a predicate yet. 1 of the 2 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK981043 Dialysol-Acid Concentrate Liquid, Granusol-Acid Concentrate Powder…Solution Technologies · 1998 · Recalled
- This deviceK071387 Fresenius Naturalyte Sodium Bicarbonate Liquid Concentrate, Model…Fresenius Medical Care North America · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981043 | Dialysol-Acid Concentrate Liquid, Granusol-Acid Concentrate Powder… | Solution Technologies | 1998 | 1 |
| 0 (this device) | K071387 | Fresenius Naturalyte Sodium Bicarbonate Liquid Concentrate, Model 08-4000-LB | Fresenius Medical Care North America | 2007 | — |
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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K981043 | Dialysol-Acid Concentrate Liquid, Granusol-Acid Concentrate Powder, Renalsol-Acetate…Summary page 2…cate Device Name: The Fresenius Naturalyte® Sodium Bicarbonate Liquid Concentrate is a modified version of the Fresenius Biosol Powder Bicarbonate Concentrate #K981043 (5/26/1998) D. Device Description/Indications for Use: The intended use for the modified device is equivalent to that of the… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 16, 2015 | Class II | Z-2373-2015 | Process control | Expansion of recall to lots manufactured in 2015 due to the potential for bacterial contamination. |
| May 20, 2015 | Class II | Z-1827-2015 | Process control | Bacterial contamination. |
| Jun 23, 2014 | Class II | Z-2686-2014 | Storage | Product was held at temperature above the labeled recommended storage temperature |
| May 1, 2014 | Class III | Z-1739-2014 | Equipment maintenance | Container cap may contain foreign material- 0.60% - 0.80% Manganese |
| Apr 10, 2014 | Class I | Z-1639-2014 | Under Investigation by firm | Naturalyte Liquid Bicarbonate maybe contaminated |
| Mar 23, 2011 | Not classified | Z-2551-2011 | Employee error | Mislabeled: incorrect lot number printed on case labels |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 2 other devices also cite its predicate K981043.
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. 2007, 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?
This concentrate is formulated to be used with a three steam hemodialysis
machine which is calibrated for acid and bicarbonate concentrates
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071387 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071387: Fresenius Naturalyte Sodium Bicarbonate Liquid Concentrate, Model 08-4000-LB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071387
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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