# K251751: Spo2 Sensor CSS032D

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Ykd Technology Co., Ltd.
- Decided: Dec 19, 2025 after 193 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: 19 generations back to K941811 (1994). 87 ancestors in all.
No later device cites it as a predicate yet.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202851: Spo2 Sensor, Jkh USA, LLC (2020) Summary page 5.

## Indications for use
YKD SpO2 sensor (Models: CSS032D) is indicated for continuous non-invasive monitoring of arterial hemoglobin oxygen saturation (SpO2) and pulse rate (PR) in adult patients (>40kg) within medical institutions. It is for fingertip use only and prohibited in emergency medical transport, home care, long-term monitoring, mobile patients, motion, and low perfusion conditions.

Source page: https://510kreport.com/device/K251751
Methodology: https://510kreport.com/methodology