510(k) · Cleared
Recalled · Class II · 2021Avl 9180 Electrolyte Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avl Scientific Corp. · JFP Electrode, Ion Specific, Calcium
Cleared on Jun 12, 1996 as substantially equivalent to K861087 (Avl Scientific Corp., 1986) and 2 other predicates after a 58-day review. Its family tree reaches back 1 generation to 1986. 47 later devices descend from it. It has been recalled once.
- Decided
- Jun 12, 1996
- Review
- 58 days
- Class
- Class II
- Product code
- JFP
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 1 generation to K861087 (1986). 3 ancestors in all. 47 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK861087 Avl Model 983 Electrolyte AnalyzerAvl Scientific Corp. · 1986
- This deviceK961458 Avl 9180 Electrolyte AnalyzerAvl Scientific Corp. · 1996
- Descendant · cites it directly · 38 of its ownK972673 Avl 9181 Electrolyte AnalyzerAvl Scientific Corp. · 1997 · Recalled
- Descendant · 2 generations on · 31 of its ownK992859 ABL700 Series Analyzer with Autocheck ModuleRadiometer America, Inc. · 2000 · Recalled
- Descendant · 3 generations on · 29 of its ownK041874 ABL800 FlexRadiometer Medical Aps · 2004 · Recalled
- Descendant · 4 generations on · 18 of its ownK050869 Modification to ABL800 FlexRadiometer Medical Aps · 2005 · Recalled
- Descendant · 4 generations on · 12 of its ownK092686 ABL90 Flex SeriesRadiometer Medical Aps · 2010 · Recalled
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 47 · See all- K972673Avl 9181 Electrolyte AnalyzerAvl Scientific Corp. · 1997 · cites it directly38descendants
- K992859ABL700 Series Analyzer with Autocheck ModuleRadiometer America, Inc. · 2000 · 2 generations on31descendants
- K041874ABL800 FlexRadiometer Medical Aps · 2004 · 3 generations on29descendants
- K050869Modification to ABL800 FlexRadiometer Medical Aps · 2005 · 4 generations on18descendants
- K092686ABL90 Flex SeriesRadiometer Medical Aps · 2010 · 4 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K861087 | Avl Model 983 Electrolyte Analyzer | Avl Scientific Corp. | 1986 | — |
| 0 (this device) | K961458 | Avl 9180 Electrolyte Analyzer | Avl Scientific Corp. | 1996 | — |
| +1 | K972673 | Avl 9181 Electrolyte Analyzer | Avl Scientific Corp. | 1997 | 7 |
| +2 | K992859 | ABL700 Series Analyzer with Autocheck Module | Radiometer America, Inc. | 2000 | 4 |
| +3 | K041874 | ABL800 Flex | Radiometer Medical Aps | 2004 | 22 |
| +4 | K050869 | Modification to ABL800 Flex | Radiometer Medical Aps | 2005 | 1 |
| +4 | K092686 | ABL90 Flex Series | Radiometer Medical Aps | 2010 | 10 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 5 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 JFP? 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 JFP device
- #1 K230300 i-STAT CG8+ cartridge with the i-STAT 1 Systemscore 6.9 · 3 generations · no Class I recall
- #2 Held for the reportin 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K861087 | Avl Model 983 Electrolyte AnalyzerSummary page 1…m, potassium and ionized calcium or sodium, potassium and lithium. The 9180, configured for sodium, potassium and chloride is equivalent to the AVL 983 Na/K/Cl Analyzer [K861087]; for sodium, potassium and ionized calcium, to the AVL 984 Na/K/iCa Analyzer [K862819] and; for sodium, potassium and lithium to… | 1986 |
| * | K862819 | Avl Model 984 Electrolyte AnalyzerSummary page 1…for sodium, potassium and chloride is equivalent to the AVL 983 Na/K/Cl Analyzer [K861087]; for sodium, potassium and ionized calcium, to the AVL 984 Na/K/iCa Analyzer [K862819] and; for sodium, potassium and lithium to the AVL 985 Na/K/Li Analyzer [K870657]. Additionally, for sodium, potassium and lithiu… | 1986 |
| * | K870657 | Avl Model 985 Electrolyte AnalyzerSummary page 1…[K861087]; for sodium, potassium and ionized calcium, to the AVL 984 Na/K/iCa Analyzer [K862819] and; for sodium, potassium and lithium to the AVL 985 Na/K/Li Analyzer [K870657]. Additionally, for sodium, potassium and lithium the AVL 9180 is substantially equivalent to the 1.L. Model 943 Flame Emission P… | 1987 |
| * | — | I.L. Model 943 Flame Emission Photometer Named without a submission number | |
| * | — | Labconco Digital Chloridometer Named without a submission number |
What descends from it? (47)
See all 476 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K972673 | Avl 9181 Electrolyte Analyzer | 1997 | 38 |
| K082462 | Gemlyte Electrolyte Analyzer NA+/K+/CL-/CA++/LI+ | 2009 | 2 |
| K070104 | Prolyte Electrolyte Analyzer | 2008 | 1 |
| K171476 | SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) | 2018 | 0 |
| K121040 | Smartlyte Electrolyte Analyzer | 2012 | 0 |
| K023792 | Calibration Pack, Models A9100-101S and A9100-103S | 2003 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 6, 2021 | Class II | Z-1098-2021 | Software design | May display Calcium results on the screen with wrong arrow direction which may lead to misinterpretation of results and incorrect medical decision. If the unit for iCa++ is set to mg/dL (configured as Service Code MGL) and a measured… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 3 ancestors has a recall.
- Of its descendants, K972673 (Avl Scientific Corp., 1997) has gone furthest, with 38 descendants of its own.
How does its category compare?
All JFP devicesJFP Electrode, Ion Specific, Calcium: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JFP
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JFP
Too few JFP 510(k)s in any year since 2007 to give a median.
Recalls per year · JFP
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JFP
40in 2025
MAUDE reports naming product code JFP, 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 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 5 |
| 2009 | 0 | — | 0 | 5 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 1 | 8 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 1 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 40 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AVL 9180 Electrolyte Analyzer is intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and lithium in whole blood, serum or plasma, urine, dialysate solutions, or QC materials as appropriate by minimally trained personnel qualified to perform and to report these values in a clinical laboratory setting. These analytes are commonly used in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders and, as such, have come to be among those which are considered by the American Association of Clinical Chemistry to have the potential of being life threatening if left uncontrolled.
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/K961458 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961458: Avl 9180 Electrolyte Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961458
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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