# K962334: EML105 Electrolyte Metabolite Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Radiometer America, Inc.
- Decided: Oct 24, 1996 after 129 days
- Product code: JGS (Electrode, Ion Specific, Sodium)
- Device class: 2
- Regulation: 21 CFR 862.1665
- 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 K952621 (1995). 1 ancestor in all.
45 later devices descend from it; 1 cites it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952621: EML105 Electrolyte Metabolite Analyzer, Radiometer America, Inc. (1995) Summary page 1.
- (no number) YSI 2300: named in the summary without a submission number

## Most influential descendants
- K980130: ABL700 Series Blood Gas , CO-Oximetry, Electrolyte & Metabolite System (1998), 44 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
- K991417: Abl 735 Analyzer (1999), 16 descendants of its own

## Recalls of this device
- Apr 7, 2011 · Not classified · Z-2571-2011: Based on internal testing and user/customer complaint reports received, the firm determined that wrinkles may arise on the outer membrane of the calcium membrane units upon installation. Retention of 

## Indications for use
EML105 is a stand alone, electrolyte metabolite analyzer that measures Na*, K*, Ca®>*, CI, glucose and lactate on whole blood and urine. It can be interfaced with an ABL analyzer 500/510/520 to become an ABL System 605/615/625 for the measurement of pH/Blood gases, electrolytes, metabolites and co-oximetry.

Source page: https://510kreport.com/device/K962334
Methodology: https://510kreport.com/methodology