# K970769: Comsat Adult,Pediatric,Infant,Neonatal,Disposable Sensor/Comsat Reusable Finger Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Aristo Medical
- Decided: Aug 28, 1997 after 178 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K060524: Dolphin 2000 Datex Compatible Oximetry Disposable and Reusable Sensors and Extension Cables (2006), 0 descendants of its own

## Indications for use
Continuous or spot monitoring of non-invasive arterial oxygen saturation.

Source page: https://510kreport.com/device/K970769
Methodology: https://510kreport.com/methodology