# K132696: Trusignal SPO2 Adult and Pediatric Adhesive Wrap Disposable Sensor

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare Finland Oy
- Decided: Sep 27, 2013 after 29 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
Longest line of descent: 5 generations back to K010463 (2001). 11 ancestors in all.
No later device cites it as a predicate yet.
3 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093881: Trusignal SPO2 Finger Sensor, Trusignal SPO2 Ear Sensor, Trusignal SPO2 Wrap Sensor, GE Healthcare Finland Oy (2010) Summary page 2.

## Indications for use
TS-AAW-10 and TS-AAW-25 The Disposable Sensor is a single-patient use sensor intended for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range: > 20 kg (>44 pounds) TS-PAW-10 and TS-PAW-25 The Disposable Sensor is a single-patient use sensor intended for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range: 3-20 kg (6.6-44 pounds)

Source page: https://510kreport.com/device/K132696
Methodology: https://510kreport.com/methodology