510(k) · Cleared
ClearedStat K System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Portable Diagnostic Services, Inc. · CEM Electrode, Ion Specific, Potassium
Cleared on Jul 16, 1992 after a 233-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.
- Decided
- Jul 16, 1992
- Review
- 233 days
- Class
- Class II
- Product code
- CEM
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK915345 Stat K SystemPortable Diagnostic Services, Inc. · 1992
- Descendant · cites it directly · 0 of its ownK042270 Stat K in Vitro Diagnostic Test SystemStat Chem, Inc. · 2004
Most influential descendants
Showing 1 of 1 · See all- K042270Stat K in Vitro Diagnostic Test SystemStat Chem, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K915345 | Stat K System | Portable Diagnostic Services, Inc. | 1992 | — |
| +1 | K042270 | Stat K in Vitro Diagnostic Test System | Stat Chem, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042270 | Stat K in Vitro Diagnostic Test System | 2004 | 0 |
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, K042270 (Stat Chem, Inc., 2004) has gone furthest, with 0 descendants of its own.
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 | — |
https://510kreport.com/device/K915345 · printed Nov 4, 2026
Cite this page
510(k) Report. “K915345: Stat K System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K915345
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026