# K202851: Spo2 Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Jkh USA, LLC
- Decided: Nov 27, 2020 after 60 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.
1 later device descends from it; 1 cites it directly.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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 4.
- K142832: Unimed Disposable and Reusable SPO2 Sensors, Unimed Medical Supplies, Inc. (2015) Summary page 4.

## Most influential descendants
- K251751: Spo2 Sensor CSS032D (2025), 0 descendants of its own

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

Source page: https://510kreport.com/device/K202851
Methodology: https://510kreport.com/methodology