# K251693: Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110-75); Unimed Reusable SpO2 Sensors (-75 Series) (U410S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U210S-75)

- Pathway: 510(k) (Traditional)
- Applicant: Unimed Medical Supplies, Inc.
- Decided: Nov 18, 2025 after 169 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: 18 generations back to K941811 (1994). 86 ancestors in all.
No later device cites it as a predicate yet.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142832: Unimed Disposable and Reusable SPO2 Sensors, Unimed Medical Supplies, Inc. (2015) Summary page 5.

## Indications for use
Unimed Reusable SpO₂ Sensors are indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate (PR) in adult patients weighing greater than 30 kg who are either well or poorly perfused. The device is intended for use under no-motion conditions in professional healthcare environments. These devices are for prescription use only.

Source page: https://510kreport.com/device/K251693
Methodology: https://510kreport.com/methodology