# K103802: Trusignal R SPO2 Peditip Sensor; Trusignal R SPO2 Peditip Sensor; Trusignal R SPO2 Peditip Sensor

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare Finland Oy
- Decided: Aug 2, 2011 after 217 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: 1 generation back to K101871 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101871: Trusignal SPO2 Fingertip Sensor, GE Healthcare Finland Oy (2010) Summary page 1.

## Cited in the summary but kept off the family tree
- K882609: Models M1175A & M1176A Component Monitoring System, Waltham Div. Hewlett Packard (1989). Our reading of the summary gave K882609, FDA’s number for Models M1175A & M1176A Component Monitoring System (Waltham Div. Hewlett Packard). Its FDA name has none of the distinctive words the summary uses for the device it names, “Philips Ml 192A Reusable SpO2 sensor”. Kept off the family tree. Summary page 1.

## Indications for use
The sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range: 15-30 kg (33-66 pounds) The sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range: 15-30 kg (33-66 pounds) The sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range: 15-30 kg (33-66 pounds)

Source page: https://510kreport.com/device/K103802
Methodology: https://510kreport.com/methodology