510(k) · Cleared
Recalled · Class II · 2017Conductivity/TDS Calibrator 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 Feb 27, 2004 as substantially equivalent to K851362 (Rna Medical Corp., 1985) after a 134-day review. Its family tree reaches back 1 generation to 1985. 2 later devices descend from it. It has been recalled once.
- Decided
- Feb 27, 2004
- Review
- 134 days
- Class
- Class II
- Product code
- FKH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K851362 (1985). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK851362 Standard Solution of Conductivity & Measurement ofRna Medical Corp. · 1985
- This deviceK033330 Conductivity/TDS Calibrator SolutionMesa Laboratories, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK191496 TDS Standard SolutionMesa Laboratories, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK130100 Comined Standard SolutionMesa Laboratories, Inc. · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K851362 | Standard Solution of Conductivity & Measurement of | Rna Medical Corp. | 1985 | — |
| 0 (this device) | K033330 | Conductivity/TDS Calibrator Solution | Mesa Laboratories, Inc. | 2004 | — |
| +1 | K191496 | TDS Standard Solution | Mesa Laboratories, Inc. | 2019 | — |
| +1 | K130100 | Comined Standard Solution | Mesa Laboratories, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2019 | 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 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 |
|---|---|---|---|
| * | K851362 | Standard Solution of Conductivity & Measurement ofSummary page 1…CFR § 876.5820 Standard Solution of Conductivity and Measurement Predicate RNA Medical Corporation Device(s) 5 10(k) Number K8 5 13 62 Cleared June 12, 1985 Performance Performance standards have not been established by the FDA under secti… | 1985 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 12, 2017 | Class II | Z-2159-2017 | Process control | Mesa Laboratories is recalling Conductivity/TDS Calibrator Solution due to failure to meet product specifications. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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.
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/TDS Calibrator Solutions are a secondary standard solution used for the
calibration of conductivity/TDS cells together with conductivity/TDS measurement
instruments. The conductivity/TDS cells and instruments may be indicated for calibrating
the conductivity 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 do not come into
contact with the patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033330 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033330: Conductivity/TDS Calibrator Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033330
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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