# K082546: Reusable Ohmeda (U410-02), Datex (U410-09) Compatable Adult Finger Clip Sensor, Phillips Adult Soft Tip Sensor (U403S-91)

- Pathway: 510(k) (Traditional)
- Applicant: Unimed Medical Supplies, Inc.
- Decided: Dec 2, 2008 after 90 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: 2 generations back to K973970 (1998). 3 ancestors in all.
15 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053420: Tenacore SP02 Sensors, Tenacore Holdings, Inc. (2006) Summary page 1.

## Most influential descendants
- K142832: Unimed Disposable and Reusable SPO2 Sensors (2015), 14 descendants of its own
- K242580: Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125) (2025), 1 descendant of its own
- K202851: Spo2 Sensor (2020), 1 descendant of its own
- K201360: Reusable and Disposable SpO2 Sensors (2020), 1 descendant of its own
- K191279: Disposable SpO2 Sensor (2019), 1 descendant of its own

## Indications for use
The SpO2 finger sensors are indicated for use to measure the approximate, non-invasive and continuous arterial oxygen saturation and pulse rate of patients weighting more than 40kg.

Source page: https://510kreport.com/device/K082546
Methodology: https://510kreport.com/methodology