# K093881: Trusignal SPO2 Finger Sensor, Trusignal SPO2 Ear Sensor, Trusignal SPO2 Wrap Sensor

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare Finland Oy
- Decided: Mar 12, 2010 after 84 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 4 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K010463 (2001). 10 ancestors in all.
2 later devices descend from it; 2 cite it directly.
3 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062576: Datex-Ohmeda S/5 E-PSM (P) Module (Consisting of E-PSM, E-PSMP and E-Intpsm Modules) and Accessories, GE Healthcare (2006) Summary page 1.
- K040831: Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500, Datex-Ohmeda, Inc. (2004) Summary page 1.
- K021955: Trutrak Plus Enhancements to the Datex-Ohmeda 3800 Series & 3900 Series Oximeters & Accessories, Datex-Ohmeda, Inc. (2002) Summary page 1.
- K992323: Datex-Ohmeda Cardiocap 5, F-MX, F-MXG and Accessories, Datex-Ohmeda, Inc. (1999) Summary page 1.

## Most influential descendants
- K250931: Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U103-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U410-121); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U110-121) (2025), 0 descendants of its own
- K132696: Trusignal SPO2 Adult and Pediatric Adhesive Wrap Disposable Sensor (2013), 0 descendants of its own

## Recalls of this device
- May 19, 2023 · Class I · Z-2030-2023: There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
- May 19, 2023 · Class I · Z-2028-2023: There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
- May 19, 2023 · Class I · Z-2029-2023: There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
- May 19, 2023 · Class I · Z-2027-2023: There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.

## Indications for use
TS-F-D The Finger Sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range > 20 kg (> 44 pounds) TS-E-D The Ear Sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. The headband is single-patient use. Patient weight range > 10 kg (> 22 pounds) TS-W-D The Wrap Sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. The tape and foam wrap are single-patient use. Patient weight range > 3 kg (> 6.6 pounds) Contraindications Sensitivity to adhesive tape may cause an allergic reaction. TS-SE-3 The Sensitive Skin Sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. The tape and foam wrap are single-patient use. Patient weight range All patients Contraindications Sensitivity to adhesive tape may cause an allergic reaction. TS-AF-10 and TS-AF-25 The AllFit Sensor is a single-patient use adhesive sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range All patients Contraindications Sensitivity to adhesive tape may cause an allergic reaction. Trusignal SpO2 Interconnect cables The Interconnect Cable is a reusable cable intended for use for all patients for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring when used with a compatible SpO2 sensor.

Source page: https://510kreport.com/device/K093881
Methodology: https://510kreport.com/methodology