# K961458: Avl 9180 Electrolyte Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Avl Scientific Corp.
- Decided: Jun 12, 1996 after 58 days
- Product code: JFP (Electrode, Ion Specific, Calcium)
- Device class: 2
- Regulation: 21 CFR 862.1145
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K861087 (1986). 3 ancestors in all.
47 later devices descend from it; 6 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K861087: Avl Model 983 Electrolyte Analyzer, Avl Scientific Corp. (1986) Summary page 1.
- K862819: Avl Model 984 Electrolyte Analyzer, Avl Scientific Corp. (1986) Summary page 1.
- K870657: Avl Model 985 Electrolyte Analyzer, Avl Scientific Corp. (1987) Summary page 1.
- (no number) I.L. Model 943 Flame Emission Photometer: named in the summary without a submission number
- (no number) Labconco Digital Chloridometer: named in the summary without a submission number

## Most influential descendants
- K972673: Avl 9181 Electrolyte Analyzer (1997), 38 descendants of its own
- K992859: ABL700 Series Analyzer with Autocheck Module (2000), 31 descendants of its own
- K041874: ABL800 Flex (2004), 29 descendants of its own
- K050869: Modification to ABL800 Flex (2005), 18 descendants of its own
- K092686: ABL90 Flex Series (2010), 12 descendants of its own

## Recalls of this device
- Jan 6, 2021 · Class II · Z-1098-2021: 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

## Indications for use
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.

Source page: https://510kreport.com/device/K961458
Methodology: https://510kreport.com/methodology