DQA · Oximeter
Cardiovascular · 21 CFR 870.2700 · Class 2
Overview
| Product Code | DQA |
|---|---|
| Device Name | Oximeter |
| Regulation | 21 CFR 870.2700 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 723)
Showing 20 most recent of 723 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260931 | Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) | Unimed Medical Supplies, Inc. | Apr 14, 2026 | SESE |
| K252448 | AViTA Pulse Oximeter (SP61) | Avita Corporation | Feb 27, 2026 | SESE |
| K252805 | YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | Feb 17, 2026 | SESE |
| K253109 | Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) | Shenzhen Best Electronics Co., Ltd. | Jan 7, 2026 | SESE |
| K251751 | Spo2 Sensor CSS032D | Shenzhen Ykd Technology Co., Ltd. | Dec 19, 2025 | SESE |
| K251696 | Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29) | Unimed Medical Supplies, Inc. | Dec 1, 2025 | SESE |
| K251691 | Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08) | Unimed Medical Supplies, Inc. | Dec 1, 2025 | SESE |
| K251695 | Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U203S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U103S-06) | Unimed Medical Supplies, Inc. | Nov 18, 2025 | SESE |
| K251693 | 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) | Unimed Medical Supplies, Inc. | Nov 18, 2025 | SESE |
| K250837 | Pulse Oximeter | Shanghai Berry Electronic Tech Co., Ltd. | Sep 25, 2025 | SESE |
| 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) | Unimed Medical Supplies, Inc. | Aug 13, 2025 | SESE |
| K241086 | Avidhrt Sense SpO2 | Avidhrt, Inc. | May 9, 2025 | SESE |
| K242876 | Pulse Oximeter ( PO2, PO2A, PO2B) | Shenzhen Viatom Technology Co., Ltd. | Feb 28, 2025 | SESE |
| K233963 | Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) | Taiwan Aulisa Medical Devices Technologies, Inc. | Feb 25, 2025 | SESE |
| K243086 | Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U410-91) | Unimed Medical Supplies, Inc. | Feb 20, 2025 | SESE |
| K242455 | AViTA Pulse Oximeter (SP62B) | Avita Corporation | Feb 19, 2025 | SESE |
| K242580 | Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125) | Unimed Medical Supplies, Inc. | Feb 6, 2025 | SESE |
| K233956 | Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) | Taiwan Aulisa Medical Devices Technologies, Inc. | Jan 30, 2025 | SESE |
| K243049 | Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C) | Hunan Accurate Bio-Medical Technology Co., Ltd. | Jan 2, 2025 | SESE |
| K241090 | Evie Med Ring | Movano Inc. Dba Movano Health | Nov 29, 2024 | SESE |
Top Applicants
- Masimo Corporation — 49 clearances
- Nonin Medical, Inc. — 42 clearances
- Masimo Corp. — 28 clearances
- Beijing Choice Electronic Technololgy Co., Ltd. — 21 clearances
- Nellcor Puritan Bennett, Inc. — 19 clearances
