510(k) · Cleared
Recalled · 2004Avl 9181 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 Aug 20, 1997 as substantially equivalent to K961458 (Avl Scientific Corp., 1996) after a 35-day review. Its family tree reaches back 2 generations to 1986. 38 later devices descend from it. It has been recalled 7 times.
- Decided
- Aug 20, 1997
- Review
- 35 days
- Class
- Class II
- Product code
- JFP
- Recalls
- 7
- Predicates
- 1
Its longest line of descent runs back 2 generations to K861087 (1986). 4 ancestors in all. 38 later devices descend from it, 7 citing it directly.
- Root · 2 generations backK861087 Avl Model 983 Electrolyte AnalyzerAvl Scientific Corp. · 1986
- 1 generation backK961458 Avl 9180 Electrolyte AnalyzerAvl Scientific Corp. · 1996 · Recalled
- This deviceK972673 Avl 9181 Electrolyte AnalyzerAvl Scientific Corp. · 1997
- Descendant · cites it directly · 31 of its ownK992859 ABL700 Series Analyzer with Autocheck ModuleRadiometer America, Inc. · 2000 · Recalled
- Descendant · 2 generations on · 29 of its ownK041874 ABL800 FlexRadiometer Medical Aps · 2004 · Recalled
- Descendant · 3 generations on · 18 of its ownK050869 Modification to ABL800 FlexRadiometer Medical Aps · 2005 · Recalled
- Descendant · 3 generations on · 12 of its ownK092686 ABL90 Flex SeriesRadiometer Medical Aps · 2010 · Recalled
- Descendant · 4 generations on · 6 of its ownK120197 ABL90 FlexRadiometer Medical Aps · 2012 · Recalled
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K992859ABL700 Series Analyzer with Autocheck ModuleRadiometer America, Inc. · 2000 · cites it directly31descendants
- K041874ABL800 FlexRadiometer Medical Aps · 2004 · 2 generations on29descendants
- K050869Modification to ABL800 FlexRadiometer Medical Aps · 2005 · 3 generations on18descendants
- K092686ABL90 Flex SeriesRadiometer Medical Aps · 2010 · 3 generations on12descendants
- K120197ABL90 FlexRadiometer Medical Aps · 2012 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K861087 | Avl Model 983 Electrolyte Analyzer | Avl Scientific Corp. | 1986 | — |
| −1 | K961458 | Avl 9180 Electrolyte Analyzer | Avl Scientific Corp. | 1996 | 1 |
| 0 (this device) | K972673 | Avl 9181 Electrolyte Analyzer | Avl Scientific Corp. | 1997 | — |
| +1 | K992859 | ABL700 Series Analyzer with Autocheck Module | Radiometer America, Inc. | 2000 | 4 |
| +2 | K041874 | ABL800 Flex | Radiometer Medical Aps | 2004 | 22 |
| +3 | K050869 | Modification to ABL800 Flex | Radiometer Medical Aps | 2005 | 1 |
| +3 | K092686 | ABL90 Flex Series | Radiometer Medical Aps | 2010 | 10 |
| +4 | K120197 | ABL90 Flex | Radiometer Medical Aps | 2012 | 3 |
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 |
|---|---|---|
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K961458 | Avl 9180 Electrolyte AnalyzerSummary page 1…M I CHEMISTRY ELECTRODE, ION-SPECIFIC, SODIUM 75JGS I CHEMISTRY (3) Substantial Equivalence The AVL 9181 is an improved design of our existing 9180 Electrolyte Analyzer [K961458] with the addition of an Autosampler to allow automatic sampling of up to 18 sample cups. The 9181 is exactly equivalent to the A… | 1996 |
| * | — | I.L. Model 943 Flame Emission Photometer Named without a submission number | |
| * | — | Labconco Digital Chloridometer Named without a submission number | |
| † | K943702 | Avl 988-4 Electrolyte Analyzer | 1994 |
What descends from it? (38)
See all 387 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992859 | ABL700 Series Analyzer with Autocheck Module | 2000 | 31 |
| K974784 | Avl Opti Critical Care Analyzer | 1998 | 5 |
| K043218 | ABL800 Flex with Flexq Module, Model ABL8XX | 2005 | 4 |
| K984299 | Avl Opti Critical Care Analyzer | 1998 | 4 |
| K993837 | Avl Opti Critical Care Analyzer | 1999 | 2 |
| K052027 | Opti Lion Electrolyte Analyzer, Model GD7200 | 2005 | 0 |
| K974779 | Abbott Alcyon (TM) 300 (Without Ise Module) and 300I (with Ise Module) Analyzer | 1998 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 21, 2004 | Not classified | Z-0608-05 | Other | A defective seam in the two chamber pouch may result in the mixing of reagents, which would either result in an inability to calibrate the analyzer or would bias patient results. |
| Dec 21, 2004 | Not classified | Z-0610-05 | Other | A defective seam in the two chamber pouch may result in the mixing of reagents, which would either result in an inability to calibrate the analyzer or would bias patient results. |
| Dec 21, 2004 | Not classified | Z-0605-05 | Other | A defective seam in the two chamber pouch may result in the mixing of reagents, which would either result in an inability to calibrate the analyzer or would bias patient results. |
| Dec 21, 2004 | Not classified | Z-0606-05 | Other | A defective seam in the two chamber pouch may result in the mixing of reagents, which would either result in an inability to calibrate the analyzer or would bias patient results. |
| Dec 21, 2004 | Not classified | Z-0607-05 | Other | A defective seam in the two chamber pouch may result in the mixing of reagents, which would either result in an inability to calibrate the analyzer or would bias patient results. |
| Dec 21, 2004 | Not classified | Z-0611-05 | Other | A defective seam in the two chamber pouch may result in the mixing of reagents, which would either result in an inability to calibrate the analyzer or would bias patient results. |
| Dec 21, 2004 | Not classified | Z-0609-05 | Other | A defective seam in the two chamber pouch may result in the mixing of reagents, which would either result in an inability to calibrate the analyzer or would bias patient results. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 1 company; a new generation was cleared every 10.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K992859 (Radiometer America, Inc., 2000) has gone furthest, with 31 descendants of its own.
- 5 other devices also cite its predicate K961458.
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 9181 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.
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/K972673 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972673: Avl 9181 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/K972673
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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