# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Unimed Medical Supplies, Inc.
- Decided: Aug 13, 2025 after 138 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 5.

## Indications for use
Unimed Reusable SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 30 kg and pediatric patients weighing 10-50 kg. These devices are for prescription use only.

Source page: https://510kreport.com/device/K250931
Methodology: https://510kreport.com/methodology