510(k) · Cleared
ClearedStat K in Vitro Diagnostic Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stat Chem, Inc. · CEM Electrode, Ion Specific, Potassium
Cleared on Oct 6, 2004 as substantially equivalent to K915345 (Portable Diagnostic Services, Inc., 1992) and 2 other predicates after a 44-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- Oct 6, 2004
- Review
- 44 days
- Class
- Class II
- Product code
- CEM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K843530 (1984). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK843530 Corning 614 NA/K AnalyzerCorning Medical & Scientific · 1984
- This deviceK042270 Stat K in Vitro Diagnostic Test SystemStat Chem, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K843530 | Corning 614 NA/K Analyzer | Corning Medical & Scientific | 1984 | — |
| 0 (this device) | K042270 | Stat K in Vitro Diagnostic Test System | Stat Chem, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2001 | 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 CEM? 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 CEM device
- #1 K253491 ISE indirect K for Gen.2; ISE indirect Na for…score 11.4 · 3 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 |
|---|---|---|---|
| * | K915345 | Stat K SystemSummary page 1…Stat K System Manufacturer: Portable Diagnostic Services, Inc. 510(k) Number: K915345 Device: SYNCHRON CX5® SYSTEM Manufacturer: Beckman C… | 1992 |
| * | K011465 | Synchron CX Pro Clinical Systems, Model CX4 Pro, CX5 Pro, CX7 Pro, CX9 ProSummary page 1…SYNCHRON CX5® SYSTEM Manufacturer: Beckman Coulter, Inc. 510(k) Number: K011465 Device: Corning 614 Na/K Analyzer Manufacturer: Corn… | 2001 |
| * | K843530 | Corning 614 NA/K AnalyzerSummary page 1…Corning 614 Na/K Analyzer Manufacturer: Corning Medical & Scientific 510(k) Number: K843530 StatChem, Inc., 510(k) Notification Page 8 of 456 Stat KIn Vitro Diagnostic Test Syst… | 1984 |
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?
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All CEM devicesCEM Electrode, Ion Specific, Potassium: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CEM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CEM
180in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CEM
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CEM
29in 2025
MAUDE reports naming product code CEM, 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 | 1 | — | 0 | 66 |
| 2008 | 0 | — | 1 | 245 |
| 2009 | 1 | — | 0 | 79 |
| 2010 | 3 | 195 | 12 | 113 |
| 2011 | 3 | 74 | 6 | 126 |
| 2012 | 4 | 180 | 0 | 45 |
| 2013 | 0 | — | 0 | 37 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 0 | — | 1 | 6 |
| 2017 | 0 | — | 0 | 32 |
| 2018 | 0 | — | 0 | 13 |
| 2019 | 0 | — | 1 | 25 |
| 2020 | 1 | — | 3 | 27 |
| 2021 | 0 | — | 1 | 18 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 2 | — | 2 | 30 |
| 2024 | 0 | — | 0 | 42 |
| 2025 | 1 | — | 4 | 29 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The StatChem Stat K is a device intended to measure potassium in anticoagulated venous whole blood and assayed within twenty minutes of collection. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. It may be used by a central laboratory or at point of care sites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042270 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042270: Stat K in Vitro Diagnostic Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042270
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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