# K100077: Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103

- Pathway: 510(k) (Traditional)
- Applicant: Solaris Medical Technology, Inc.
- Decided: Oct 7, 2010 after 268 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: 7 generations back to K941811 (1994). 34 ancestors in all.
22 later devices descend from it; 4 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993637: N-395 Pulse Oximeter, with Extended Device Claims, Nellcor Puritan Bennett, Inc. (1999) Summary page 1.
- K050056: Model 2500A Palmsat Pulse Oximeter, Nonin Medical, Inc. (2005) Summary page 2.
- K000822: Agilentcomponent Monitoring System, Agilent 24/26, Agilent Multi-Measurement Server and Compact Portable Patient Monitor, Agilent Technologies, GmbH (2000) Summary page 2.
- K042306: Philips SP02 Disposable Sensor, Model M1131A, Philips Medizin Systeme Boeblingen GmbH (2004) Summary page 2.
- K083705: Bci WW1020 Pulse Oximeter, Model WW1020, Smiths Medical Pm, Inc. (2009) Summary page 2.

## Most influential descendants
- K142832: Unimed Disposable and Reusable SPO2 Sensors (2015), 14 descendants of its own
- K153184: Caremed Reusable & Disposable SPO2 Sensors (2017), 5 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

## Indications for use
When used with a compatible patient monitor or a pulse oximeter device, Solaris Medical Technology, Inc. reusable & disposable SpO2 sensors are intended to be used for continuous, non-invasive functional arterial oxygen saturation (SpO2) and pulse rate monitoring. Solaris Medical Technology, Inc. reusable multi-patient use SpO2 Soft Sensors, reusable multi-patient use SpO2 Finger Sensors, and disposable single patient use SpO2 Soft-finger Sensors are for use with adult/pediatric patients weighing greater than 40kg. Solaris Medical Technology, Inc. disposable single patient use SpO2 Adhesive Sensors are for use with adult patients weighing greater than 40kg, pediatric patients weighing 10 - 40 kg, and infant (non-neonatal) patients weighing 3 - 15 kg.

Source page: https://510kreport.com/device/K100077
Methodology: https://510kreport.com/methodology