510(k) K250931

Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U103-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U410-121); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U110-121) by Unimed Medical Supplies, Inc. — Product Code DQA

K250931 is an FDA 510(k) premarket notification submitted by Unimed Medical Supplies, Inc. for the device "Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U103-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U410-121); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U110-121)". The FDA issued a decision of Substantially Equivalent on August 13, 2025. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Unimed Medical Supplies, Inc. has at least 10 other 510(k) clearances on record.