510(k) · Cleared
ClearedStandard Solution of Conductivity & Measurement of
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rna Medical Corp. · FKH Solution-Test Standard-Conductivity, Dialysis
Cleared on Jun 12, 1985 after a 69-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jun 12, 1985
- Review
- 69 days
- Class
- Class II
- Product code
- FKH
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK851362 Standard Solution of Conductivity & Measurement ofRna Medical Corp. · 1985
- Descendant · cites it directly · 2 of its ownK033330 Conductivity/TDS Calibrator SolutionMesa Laboratories, Inc. · 2004 · Recalled
- Descendant · cites it directly · 1 of its ownK032075 Conductivity Standard Solution-MetercareIbp Instruments GmbH · 2003
- Descendant · 2 generations on · 0 of its ownK191496 TDS Standard SolutionMesa Laboratories, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK130100 Comined Standard SolutionMesa Laboratories, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK041636 H&S-Conductivity Standard SolutionH & S Technical Services · 2004 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K033330Conductivity/TDS Calibrator SolutionMesa Laboratories, Inc. · 2004 · cites it directly2descendants
- K032075Conductivity Standard Solution-MetercareIbp Instruments GmbH · 2003 · cites it directly1descendant
- K191496TDS Standard SolutionMesa Laboratories, Inc. · 2019 · 2 generations on0descendants
- K130100Comined Standard SolutionMesa Laboratories, Inc. · 2013 · 2 generations on0descendants
- K041636H&S-Conductivity Standard SolutionH & S Technical Services · 2004 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K851362 | Standard Solution of Conductivity & Measurement of | Rna Medical Corp. | 1985 | — |
| +1 | K033330 | Conductivity/TDS Calibrator Solution | Mesa Laboratories, Inc. | 2004 | 1 |
| +1 | K032075 | Conductivity Standard Solution-Metercare | Ibp Instruments GmbH | 2003 | — |
| +2 | K191496 | TDS Standard Solution | Mesa Laboratories, Inc. | 2019 | — |
| +2 | K130100 | Comined Standard Solution | Mesa Laboratories, Inc. | 2013 | — |
| +2 | K041636 | H&S-Conductivity Standard Solution | H & S Technical Services | 2004 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2013 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K033330 (Mesa Laboratories, Inc., 2004) has gone furthest, with 2 descendants of its own.
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 | — |
https://510kreport.com/device/K851362 · printed Nov 6, 2026
Cite this page
510(k) Report. “K851362: Standard Solution of Conductivity & Measurement of.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K851362
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026