DQA — Oximeter Class II
FDA product code DQA covers "Oximeter", a Class II medical device regulated under 21 CFR 870.2700. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252821 | philips medizin systeme böblingen | Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor ( | May 29, 2026 |
| K252655 | shenzhen imdk medical technology co | Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, P | May 11, 2026 |
| K253887 | philips medizin systeme | Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Na | May 1, 2026 |
| K260931 | unimed medical supplies | Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) | April 14, 2026 |
| K252448 | avita corporation | AViTA Pulse Oximeter (SP61) | February 27, 2026 |
| K252805 | jiangsu yuyue medical equipment and supply co | YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) | February 17, 2026 |
| K253109 | shenzhen best electronics co | Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) | January 7, 2026 |
| K251751 | shenzhen ykd technology co | Spo2 Sensor CSS032D | December 19, 2025 |
| K251691 | unimed medical supplies | Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Senso | December 1, 2025 |
| K251696 | unimed medical supplies | Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusa | December 1, 2025 |
| K251693 | unimed medical supplies | Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensor | November 18, 2025 |
| K251695 | unimed medical supplies | Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Senso | November 18, 2025 |
| K250837 | shanghai berry electronic tech co | Pulse Oximeter | September 25, 2025 |
| K250931 | unimed medical supplies | Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable | August 13, 2025 |
| K241086 | avidhrt | Avidhrt Sense SpO2 | May 9, 2025 |
| K242876 | shenzhen viatom technology co | Pulse Oximeter ( PO2, PO2A, PO2B) | February 28, 2025 |
| K233963 | taiwan aulisa medical devices technologies | Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) | February 25, 2025 |
| K243086 | unimed medical supplies | Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reus | February 20, 2025 |
| K242455 | avita corporation | AViTA Pulse Oximeter (SP62B) | February 19, 2025 |
| K242580 | unimed medical supplies | Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip | February 6, 2025 |