# K973367: ABL555 Blood Gas, Electrolyte & Metabolite System

- Pathway: 510(k) (Traditional)
- Applicant: Radiometer America, Inc.
- Decided: Oct 6, 1997 after 28 days
- Product code: CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph)
- Device class: 2
- Regulation: 21 CFR 862.1120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K914166 (1992). 1 ancestor in all.
46 later devices descend from it; 2 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914166: ABL505 Blood Gas & Electrolyte System, Radiometer America, Inc. (1992) Summary page 1.
- (no number) EML105: 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

## Indications for use
ABLSSS is a stand alone, blood gas, electrolyte and metabolite analyzer that measures pH, O,, pO,, Na*, K*, and glucose on whole blood.

Source page: https://510kreport.com/device/K973367
Methodology: https://510kreport.com/methodology