510(k) · Cleared
ClearedAlcyon 300I (with Ise Module) Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · CEM Electrode, Ion Specific, Potassium
Cleared on Oct 5, 1999 after a 20-day review. The FDA summary names no predicate by number.
- Decided
- Oct 5, 1999
- Review
- 20 days
- Class
- Class II
- Product code
- CEM
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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?
The FDA summary names no predicate by number.
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.
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?
Per 21 CFR,-682.2160, the ALCYON Analyzer is a discrete photometric chemistry analyzer for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. The analyzer with the optional Ion-Selective Electrode (ISE) Module measures the concentration of the electrolytes, sodium, potassium, and chloride, in samples using indirect potentiometry.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993083 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993083: Alcyon 300I (with Ise Module) Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993083
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026