510(k) · Cleared
ClearedAbbott Alcyon (TM) 300 (Without Ise Module) and 300I (with Ise Module) Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Cleared on Feb 13, 1998 as substantially equivalent to K935662 (Synermed, Inc., 1994) and 3 other predicates after a 53-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- Feb 13, 1998
- Review
- 53 days
- Class
- Class I
- Product code
- JJE
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K861087 (1986). 8 ancestors in all, the oldest K791312 (1979). No later device cites it as a predicate yet.
- Root · 3 generations backK861087 Avl Model 983 Electrolyte AnalyzerAvl Scientific Corp. · 1986
- 2 generations backK961458 Avl 9180 Electrolyte AnalyzerAvl Scientific Corp. · 1996 · Recalled
- 1 generation backK972673 Avl 9181 Electrolyte AnalyzerAvl Scientific Corp. · 1997 · Recalled
- This deviceK974779 Abbott Alcyon (TM) 300 (Without Ise Module) and 300I (with Ise…Abbott Laboratories · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K861087 | Avl Model 983 Electrolyte Analyzer | Avl Scientific Corp. | 1986 | — |
| −2 | K961458 | Avl 9180 Electrolyte Analyzer | Avl Scientific Corp. | 1996 | 1 |
| −1 | K972673 | Avl 9181 Electrolyte Analyzer | Avl Scientific Corp. | 1997 | 7 |
| 0 (this device) | K974779 | Abbott Alcyon (TM) 300 (Without Ise Module) and 300I (with Ise Module) Analyzer | Abbott Laboratories | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1983 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1994 | 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 JJE? 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? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K935662 | Synermed IR 500 Chemistry AnalyzerSummary page 2…direct potentiometry. Substantial Equivalence: Substantial equivalence has been demonstrated between the ALCYON 300 Analyzer, the Synermed ™ IR 500 Chemistry Analyzer (K935662), and the Roche® Cobas® Mira Plus (K9720402). The ALCYON 300 Analyzer, the Synermed ™ IR 500 Chemistry Analyzer, ALCYON Analyzer… | 1994 |
| Kept off the family tree | K972040 | Roche Cobas Mira Plus Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2…nce: Substantial equivalence has been demonstrated between the ALCYON 300 Analyzer, the Synermed ™ IR 500 Chemistry Analyzer (K935662), and the Roche® Cobas® Mira Plus (K9720402). The ALCYON 300 Analyzer, the Synermed ™ IR 500 Chemistry Analyzer, ALCYON Analyzer 510(k) December 19, 1997 10:19 AM Final 0… | |
| * | K823480 | IL 943 Flame PhotometerSummary page 3…by measuring change in absorbance per unit of time. Substantial equivalence has also been demonstrated between the ALCYON 300i and the 1.943™ Automatic Flame Photometer (K823480), the Buchler Instruments Digital Chloridometer (K791312), and the AVL 9181 Electrolyte Analyzer (K972673). All four analyzers ar… | 1983 |
| * | K791312 | Catalog #4-2520 Chloridometer ChlorideSummary page 3…antial equivalence has also been demonstrated between the ALCYON 300i and the 1.943™ Automatic Flame Photometer (K823480), the Buchler Instruments Digital Chloridometer (K791312), and the AVL 9181 Electrolyte Analyzer (K972673). All four analyzers are used to analyze for electrolytes. All analyzers are cal… | 1979 |
| * | K972673 | Avl 9181 Electrolyte AnalyzerSummary page 3…ween the ALCYON 300i and the 1.943™ Automatic Flame Photometer (K823480), the Buchler Instruments Digital Chloridometer (K791312), and the AVL 9181 Electrolyte Analyzer (K972673). All four analyzers are used to analyze for electrolytes. All analyzers are calibrated with known concentration calibrator mater… | 1997 |
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?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 8 ancestors have a recall of any class.
How does its category compare?
All JJE devicesJJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJE
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · JJE
224in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJE
6in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJE
4,400in 2025
MAUDE reports naming product code JJE, 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 | — | 20 | 2,181 |
| 2008 | 1 | — | 20 | 2,159 |
| 2009 | 0 | — | 14 | 3,440 |
| 2010 | 0 | — | 32 | 3,273 |
| 2011 | 2 | — | 25 | 11,606 |
| 2012 | 1 | — | 16 | 3,707 |
| 2013 | 1 | — | 21 | 2,489 |
| 2014 | 3 | 224 | 14 | 2,841 |
| 2015 | 0 | — | 15 | 2,793 |
| 2016 | 0 | — | 9 | 2,580 |
| 2017 | 0 | — | 18 | 1,869 |
| 2018 | 0 | — | 17 | 4,590 |
| 2019 | 1 | — | 7 | 3,948 |
| 2020 | 0 | — | 7 | 3,986 |
| 2021 | 0 | — | 6 | 3,920 |
| 2022 | 0 | — | 0 | 3,998 |
| 2023 | 0 | — | 12 | 3,783 |
| 2024 | 0 | — | 6 | 4,221 |
| 2025 | 0 | — | 6 | 4,400 |
| 2026 | 0 | — | 5 | — |
What is it indicated for?
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/K974779 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974779: Abbott Alcyon (TM) 300 (Without Ise Module) and 300I (with Ise Module) Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974779
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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