# K972673: Avl 9181 Electrolyte Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Avl Scientific Corp.
- Decided: Aug 20, 1997 after 35 days
- Product code: JFP (Electrode, Ion Specific, Calcium)
- Device class: 2
- Regulation: 21 CFR 862.1145
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K861087 (1986). 4 ancestors in all.
38 later devices descend from it; 7 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961458: Avl 9180 Electrolyte Analyzer, Avl Scientific Corp. (1996) 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
- 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
- K120197: ABL90 Flex (2012), 6 descendants of its own

## Recalls of this device
- Dec 21, 2004 · Not classified · Z-0608-05: 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: 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: 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: 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: 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: 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: 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K972673
Methodology: https://510kreport.com/methodology