510(k) · Cleared
ClearedDPC T60I Kusti, Model 984248; DPC T60I, Model 984247
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermo Electron OY · CEM Electrode, Ion Specific, Potassium
Cleared on Aug 8, 2006 after a 110-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Aug 8, 2006
- Review
- 110 days
- Class
- Class II
- Product code
- CEM
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK061107 DPC T60I Kusti, Model 984248; DPC T60I, Model 984247Thermo Electron OY · 2006
- Descendant · cites it directly · 0 of its ownK110035 IndikoThermofisher Scientific OY · 2011 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K110035IndikoThermofisher Scientific OY · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061107 | DPC T60I Kusti, Model 984248; DPC T60I, Model 984247 | Thermo Electron OY | 2006 | — |
| +1 | K110035 | Indiko | Thermofisher Scientific OY | 2011 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K110035 | Indiko | 2011 | 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, K110035 (Thermofisher Scientific OY, 2011) 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 | — |
What is it indicated for?
The DPC T60i and DPC T60i Kusti Clinical Chemistry Analyzers are fully automated random access analyzers for in-vitro diagnostic use with clinical laboratory assays validated for use on these instrument platforms, including an ISE unit with Na+, K+ and Cl- electrodes. The DPC T60 Glucose (HK) test system with associated Calibrators and Controls is intended for quantitative in-vitro diagnostic determination of glucose in serum or plasma using the DPC T60i…
Read the full statement (193 words)
The DPC T60i and DPC T60i Kusti Clinical Chemistry Analyzers are fully automated
random access analyzers for in-vitro diagnostic use with clinical laboratory assays
validated for use on these instrument platforms, including an ISE unit with Na+, K+ and
Cl- electrodes.
The DPC T60 Glucose (HK) test system with associated Calibrators and Controls is
intended for quantitative in-vitro diagnostic determination of glucose in serum or plasma
using the DPC T60i and DPC T60i Kusti Clinical Chemistry Analyzers. Glucose
measurements are used in the diagnosis and treatment of carbohydrate metabolism
disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic
hypoglycemia, and of pancreatic islet cell carcinoma.
The DPC ISE Micro Volume Chloride, Potassium and Sodium Electrodes with
associated Calibrators are intended for quantitative in-vitro diagnostic determination of
Chloride, Potassium and Sodium in serum or plasma using the DPC T60i and DPC
T60i Kusti Clinical Chemistry Analyzers.
Chloride measurements are used in the diagnosis and treatment of electrolyte and
metabolic disorders.
Potassium measurements monitor electrolyte balance and in the diagnosis and
treatment of diseases conditions characterized by low or high blood potassium levels.
Sodium measurements are used in the diagnosis and treatment diseases involving
electrolyte imbalance.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K061107 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061107: DPC T60I Kusti, Model 984248; DPC T60I, Model 984247.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061107
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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