DQA — Oximeter Class II

FDA Device Classification

Classification Details

Product Code
DQA
Device Class
Class II
Regulation Number
870.2700
Submission Type
Review Panel
AN
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252448avita corporationAViTA Pulse Oximeter (SP61)February 27, 2026
K252805jiangsu yuyue medical equipment and supply coYUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)February 17, 2026
K253109shenzhen best electronics coReusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)January 7, 2026
K251751shenzhen ykd technology coSpo2 Sensor CSS032DDecember 19, 2025
K251696unimed medical suppliesUnimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed ReusaDecember 1, 2025
K251691unimed medical suppliesUnimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 SensoDecember 1, 2025
K251693unimed medical suppliesUnimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 SensorNovember 18, 2025
K251695unimed medical suppliesUnimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 SensoNovember 18, 2025
K250837shanghai berry electronic tech coPulse OximeterSeptember 25, 2025
K250931unimed medical suppliesUnimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable August 13, 2025
K241086avidhrtAvidhrt Sense SpO2May 9, 2025
K242876shenzhen viatom technology coPulse Oximeter ( PO2, PO2A, PO2B)February 28, 2025
K233963taiwan aulisa medical devices technologiesAulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)February 25, 2025
K243086unimed medical suppliesUnimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed ReusFebruary 20, 2025
K242455avita corporationAViTA Pulse Oximeter (SP62B)February 19, 2025
K242580unimed medical suppliesUnimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger ClipFebruary 6, 2025
K233956taiwan aulisa medical devices technologiesAulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)January 30, 2025
K243049hunan accurate bio-medical technology coPulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)January 2, 2025
K241090movano inc. dba movano healthEvie Med RingNovember 29, 2024
K232520shenzhen smallsignal technology coFingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, AlpNovember 21, 2024