510(k) · Cleared
Recalled · Class II · 2022Fresenius Naturalyte Liquid Acid Concentrate, 9000, 6000 and 4000 Series
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 Mar 29, 2007 as substantially equivalent to K810925 (Erika, Inc., 1981) and 2 other predicates after a 70-day review. Its family tree reaches back 1 generation to 1981. It has been recalled 35 times.
- Decided
- Mar 29, 2007
- Review
- 70 days
- Class
- Class II
- Product code
- KPO
- Recalls
- 35
- Predicates
- 3
Its longest line of descent runs back 1 generation to K810925 (1981). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK810925 Naturalyte Bicarbonate Dialysate Concen.Erika, Inc. · 1981
- This deviceK070177 Fresenius Naturalyte Liquid Acid Concentrate, 9000, 6000 and 4000…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 | K810925 | Naturalyte Bicarbonate Dialysate Concen. | Erika, Inc. | 1981 | — |
| 0 (this device) | K070177 | Fresenius Naturalyte Liquid Acid Concentrate, 9000, 6000 and 4000 Series | Fresenius Medical Care North America | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1985 | 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 |
|---|---|---|---|
| * | K810925 | Naturalyte Bicarbonate Dialysate Concen.Summary page 2…. Predicate Device Name: The Fresenius Naturalyte® Liquid Acid Concentrate is a modified version of the Fresenius Naturalyte Liquid Acid Concentrate1996): * #K810925 (4/23/1981)- 9000 series * #K823115 (12/3/1982) - 4000 series * #K852310 (7/26/1985) - 6000 series D. Device Description/ind… | 1981 |
| * | K823115 | Naturalyte Bicarbonate Dialysate 4400Summary page 2…enius Naturalyte® Liquid Acid Concentrate is a modified version of the Fresenius Naturalyte Liquid Acid Concentrate1996): * #K810925 (4/23/1981)- 9000 series * #K823115 (12/3/1982) - 4000 series * #K852310 (7/26/1985) - 6000 series D. Device Description/indications for Use: The intended us… | 1982 |
| * | K852310 | Naturalyte Bicarbonate Concentrate-Dry PackSummary page 2…te is a modified version of the Fresenius Naturalyte Liquid Acid Concentrate1996): * #K810925 (4/23/1981)- 9000 series * #K823115 (12/3/1982) - 4000 series * #K852310 (7/26/1985) - 6000 series D. Device Description/indications for Use: The intended use for the modified device is equivalent… | 1985 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 4, 2022 | Class II | Z-0181-2023 | Error in labeling | The "Nominal Chemical Composition" section of the label incorrectly lists 5.62g/L KCL (potassium chloride). 5.62g/L actually corresponds to the CaCl (calcium chloride) content. The product remains potassium free. |
| Dec 17, 2020 | Class II | Z-0942-2021 | Packaging change control | Bottles Missing Product Label |
| Nov 23, 2020 | Class II | Z-0832-2021 | Under Investigation by firm | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing… |
| Nov 23, 2020 | Class II | Z-0834-2021 | Under Investigation by firm | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing… |
| Nov 23, 2020 | Class II | Z-0836-2021 | Under Investigation by firm | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing… |
| Nov 23, 2020 | Class II | Z-0838-2021 | Under Investigation by firm | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing… |
| Nov 23, 2020 | Class II | Z-0833-2021 | Under Investigation by firm | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing… |
| Nov 23, 2020 | Class II | Z-0841-2021 | Under Investigation by firm | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing… |
| Nov 23, 2020 | Class II | Z-0835-2021 | Under Investigation by firm | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing… |
| Nov 23, 2020 | Class II | Z-0837-2021 | Under Investigation by firm | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing… |
| Nov 23, 2020 | Class II | Z-0840-2021 | Under Investigation by firm | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing… |
| Nov 23, 2020 | Class II | Z-0831-2021 | Under Investigation by firm | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing… |
| Nov 23, 2020 | Class II | Z-0839-2021 | Under Investigation by firm | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing… |
| Nov 7, 2020 | Class II | Z-0811-2021 | Under Investigation by firm | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| Nov 7, 2020 | Class II | Z-0812-2021 | Under Investigation by firm | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| Nov 7, 2020 | Class II | Z-0813-2021 | Under Investigation by firm | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| Nov 7, 2020 | Class II | Z-0815-2021 | Under Investigation by firm | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| Nov 7, 2020 | Class II | Z-0816-2021 | Under Investigation by firm | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| Nov 7, 2020 | Class II | Z-0817-2021 | Under Investigation by firm | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| Nov 7, 2020 | Class II | Z-0818-2021 | Under Investigation by firm | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| Nov 7, 2020 | Class II | Z-0820-2021 | Under Investigation by firm | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| Nov 7, 2020 | Class II | Z-0821-2021 | Under Investigation by firm | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| Nov 7, 2020 | Class II | Z-0823-2021 | Under Investigation by firm | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| Nov 7, 2020 | Class II | Z-0825-2021 | Under Investigation by firm | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| Nov 7, 2020 | Class II | Z-0826-2021 | Under Investigation by firm | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| Nov 7, 2020 | Class II | Z-0827-2021 | Under Investigation by firm | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| Nov 7, 2020 | Class II | Z-0814-2021 | Under Investigation by firm | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| Nov 7, 2020 | Class II | Z-0819-2021 | Under Investigation by firm | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| Nov 7, 2020 | Class II | Z-0822-2021 | Under Investigation by firm | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| Nov 7, 2020 | Class II | Z-0824-2021 | Under Investigation by firm | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| Nov 7, 2020 | Class II | Z-0828-2021 | Under Investigation by firm | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| Nov 7, 2020 | Class II | Z-0829-2021 | Under Investigation by firm | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| May 2, 2018 | Class II | Z-2110-2018 | Employee error | The bottles are mislabeled with an incorrect part number. |
| Sep 29, 2017 | Class II | Z-1010-2018 | Release of Material/Component prior to receiving test results | The label specifies the potassium concentration is 2.0 mEq/L. Some of the product in the affected lot was found to have a potassium concentration of 2.25 mEq/L. |
| Jan 18, 2016 | Class II | Z-0887-2016 | Error in labeling | On the label calcium (Ca) listed in the right upper corner of the label (red background) incorrectly indicates the product contains 2.5 mEq/L Ca. The concentration indicated in the list of constituents represents the actual calcium… |
The 5 latest of 35 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K810925.
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
2007high 5 (2020) · low 0 (2010)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · KPO
112in 2024
2007high 270 (2020) · low 112 (2024)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPO
6in 2025
2007high 31 (2020) · low 0 (2010)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPO
95in 2025
2007high 15,916 (2014) · low 3 (2009)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 for Bicarbonate Dialysis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070177 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070177: Fresenius Naturalyte Liquid Acid Concentrate, 9000, 6000 and 4000 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070177
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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