Atlas FDA

Spo2 Sensor CSS032D

FDA 510(k) clearance K251751 · decided 2025-12-19

Clearance details

K-number
K251751
Device name
Spo2 Sensor CSS032D
Applicant
Shenzhen Ykd Technology Co., Ltd.
Decision
Substantially Equivalent
Date received
2025-06-09
Decision date
2025-12-19
Days to decision
193 days
Clearance type
Traditional
Product code
DQA
Device class
2
Regulation number
870.2700
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Shenzhen, CN
Third-party review
No
Expedited review
No

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Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29) (K251696)Unimed Medical Supplies, Inc.2025-12-01
Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U203S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U103S-06) (K251695)Unimed Medical Supplies, Inc.2025-11-18
Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110-75); Unimed Reusable SpO2 Sensors (-75 Series) (U410S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U210S-75) (K251693)Unimed Medical Supplies, Inc.2025-11-18
Pulse Oximeter (K250837)Shanghai Berry Electronic Tech Co., Ltd.2025-09-25

Recalls involving this device

No recalls on record reference this clearance.