# K142832: Unimed Disposable and Reusable SPO2 Sensors

- Pathway: 510(k) (Traditional)
- Applicant: Unimed Medical Supplies, Inc.
- Decided: Feb 6, 2015 after 129 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: 17 generations back to K941811 (1994). 85 ancestors in all.
14 later devices descend from it; 10 cite it directly.
0 of 100 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100077: Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103, Solaris Medical Technology, Inc. (2010) Summary page 4.
- K111888: Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry Sensors, Masimo Corporation (2011) Summary page 4.
- K082546: Reusable Ohmeda (U410-02), Datex (U410-09) Compatable Adult Finger Clip Sensor, Phillips Adult Soft Tip Sensor (U403S-91), Unimed Medical Supplies, Inc. (2008) Summary page 5.

## Most influential descendants
- 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
- K260931: Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) (2026), 0 descendants of its own

## Indications for use
Unimed Disposable and 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 40kg, pediatric patients weighing 10 -50 kg, and neonatal patients weighing no less than 3 Kg.

Source page: https://510kreport.com/device/K142832
Methodology: https://510kreport.com/methodology