AViTA Pulse Oximeter (SP61)
FDA 510(k) K252448 · Avita Corporation
510(k) numberK252448
Submission
- Device name
- AViTA Pulse Oximeter (SP61)
- Applicant
- Avita Corporation
New Taipei City, CN - Received
- August 4, 2025
- Decision date
- February 27, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQA – Oximeter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2700
- Specialty
- Cardiovascular
Other 510(k)s with product code DQA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252821 | Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m)…DQA · Traditional | Philips Medizin Systeme Böblingen GmbH | 05/29/2026SE |
| K252655 | Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO…DQA · Traditional | Shenzhen Imdk Medical Technology Co., Ltd. | 05/11/2026SE |
| K253887 | Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar…DQA · Traditional | Philips Medizin Systeme | 05/01/2026SE |
| K260931 | Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)DQA · Special | Unimed Medical Supplies, Inc. | 04/14/2026SE |
| K252805 | YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)DQA · Traditional | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 02/17/2026SE |
| K253109 | Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)DQA · Traditional | Shenzhen Best Electronics Co., Ltd. | 01/07/2026SE |
| K251751 | Spo2 Sensor CSS032DDQA · Traditional | Shenzhen Ykd Technology Co., Ltd. | 12/19/2025SE |
| K251696 | Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2…DQA · Traditional | Unimed Medical Supplies, Inc. | 12/01/2025SE |
| K251691 | Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08…DQA · Traditional | Unimed Medical Supplies, Inc. | 12/01/2025SE |
| K251695 | Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06…DQA · Traditional | Unimed Medical Supplies, Inc. | 11/18/2025SE |
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| 510(k) | Device | Decision |
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| K250129 | AViTA Breast PumpHGX · Traditional | 06/11/2026SE |
| K250765 | AViTA Arm Type Blood Pressure Monitor CuffDXQ · Traditional | 09/03/2025SE |
| K242455 | AViTA Pulse Oximeter (SP62B)DQA · Traditional | 02/19/2025SE |
| K241852 | Nasal Aspirator (NS 13)BTA · Traditional | 12/31/2024SE |
| K242193 | Arm Type Blood Pressure Monitor (BPM82)DXN · Traditional | 10/22/2024SE |
| K223399 | AViTA Pulse OximeterDQA · Traditional | 05/20/2024SE |
| K200346 | Wrist Type Blood Pressure MonitorDXN · Traditional | 12/17/2020SE |
| K180155 | Arm Type Blood Pressure MonitorDXN · Traditional | 08/03/2018SE |
| K172427 | AViTA Radar Thermo NT16 Series IR ThermometerFLL · Traditional | 04/19/2018SE |
| K112825 | Avita Arm Type Blood Pressure MonitorDXN · Traditional | 01/18/2012SE |
Questions and answers
When was AViTA Pulse Oximeter (SP61) cleared by the FDA?
AViTA Pulse Oximeter (SP61) (K252448) received a 510(k) decision of Substantially Equivalent on February 27, 2026, 207 days after the submission was received.
What is the product code of K252448?
The FDA product code is DQA – Oximeter, a Class II (moderate risk) device regulated under 21 CFR 870.2700.