# K954612: Abl System 625, 615, 605

- Pathway: 510(k) (Traditional)
- Applicant: Radiometer America, Inc.
- Decided: Nov 9, 1995 after 35 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K033060: Calibrating Material, Calibrating Standards (2004), 0 descendants of its own
- K972733: Avl Omni Analyzer (1997), 0 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/K954612
Methodology: https://510kreport.com/methodology