510(k) · Cleared
ClearedComined Standard Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mesa Laboratories, Inc. · FKH Solution-Test Standard-Conductivity, Dialysis
Cleared on Apr 18, 2013 as substantially equivalent to K033330 (Mesa Laboratories, Inc., 2004) after a 93-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- Apr 18, 2013
- Review
- 93 days
- Class
- Class II
- Product code
- FKH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K851362 (1985). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 FKH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K033330 | Conductivity/TDS Calibrator SolutionSummary page 1…Product Code FKH Predicate ConductivitylTDS Calibrator Solution Device(s): Mesa Laboratories Inc 510(k) Number K033330 Cleared February 27, 2004 Device The device consists of salts (Sodium Chloride, Sodium De… | 2004 |
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 18.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K033330.
How does its category compare?
All FKH devicesFKH Solution-Test Standard-Conductivity, Dialysis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · FKH
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · FKH
Too few FKH 510(k)s in any year since 2007 to give a median.
Recalls per year · FKH
No recall names FKH since 2007.
Adverse event reports per year · FKH
2in 2013
MAUDE reports naming product code FKH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Conductivity/pH Calibrator Solutions are a secondary standard solution used for the calibration of conductivity/TDS cells together with conductivity/TDS and pH measurement instruments. The conductivity/TDS cells and instruments may be indicated for calibrating the conductivity and pH measurement function of hemodialysis machines and water purification equipment for hemodialysis, or for verifying proper function of hemodialysis machine or water purification equipment measurement functions. These solutions are used remotely from the hemodialysis machine or water purification equipment, and does not come into contact with the patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130100 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130100: Comined Standard Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130100
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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