# K153184: Caremed Reusable & Disposable SPO2 Sensors

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Caremed Medical Technology Co., Ltd.
- Decided: Jan 4, 2017 after 428 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). 81 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 87 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.

## Most influential descendants
- K181270: Disposable SpO2 Sensors, Reusable SpO2 Sensors (2018), 1 descendant of its own
- K253109: Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) (2026), 0 descendants of its own
- K192608: Disposable SpO2 Sensor (2020), 0 descendants of its own
- K173368: Reusable & Disposable SpO2 Sensors (2018), 0 descendants of its own
- K172981: Reusable SpO2 Sensors, Disposable SpO2 Sensors (2018), 0 descendants of its own

## Indications for use
Caremed Reusable & Disposable 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 40 kg and pediatric patients weighing 10 -50 kg at hospital facilities

Source page: https://510kreport.com/device/K153184
Methodology: https://510kreport.com/methodology