# K914166: ABL505 Blood Gas & Electrolyte System

- Pathway: 510(k) (Traditional)
- Applicant: Radiometer America, Inc.
- Decided: Jan 28, 1992 after 133 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
47 later devices descend from it; 1 cites 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K973367: ABL555 Blood Gas, Electrolyte & Metabolite System (1997), 46 descendants of its own
- 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

## 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 

Source page: https://510kreport.com/device/K914166
Methodology: https://510kreport.com/methodology