# K152553: CueSee Hypoxic

- Pathway: 510(k) (Traditional)
- Applicant: Eurotrol B.V.
- Decided: Apr 22, 2016 after 227 days
- Product code: JJS (Controls For Blood-Gases, (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K913133 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032453: Roche Combitrol and Autotrol Plus B Multi Analyte Control, Bionostics, Inc. (2003) Summary page 4.

## Indications for use
CueSee® Hypoxic is a pre-tonometered bovine hemoglobin (Hb) quality control material for professional use for monitoring blood gas analyzers’ performance of Oxygen partial pressure (pO2).

Source page: https://510kreport.com/device/K152553
Methodology: https://510kreport.com/methodology