Recent 510(k) Predicates for DQA Pulse Oximeters
Researched with the BEUDAMED Research Assistant on July 11, 2026. Answers are generated from the BEUDAMED database and cite their records — verify time-critical facts against official sources.
For FDA product code DQA (Oximeter)—a Class II device category under 21 CFR 870.2700—the most recent substantially equivalent 510(k) clearances in the data are: DQA classification
| Decision date | 510(k) | Device | Applicant |
|---|---|---|---|
| 2026-05-29 | K252821 | Reusable Adult SpO2 Clip Sensors (M1196A/M1196T) | Philips Medizin Systeme Böblingen GmbH |
| 2026-05-11 | K252655 | Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO/AT, PO-C6AO/AT) | Shenzhen Imdk Medical Technology Co., Ltd. |
| 2026-05-01 | K253887 | Nasal Alar SpO2 Sensors | Philips Medizin Systeme |
| 2026-04-14 | K260931 | Unimed Reusable Finger Clip SpO2 Sensors (U403-49R/U103-49R) | Unimed Medical Supplies, Inc. |
| 2026-02-27 | K252448 | AViTA Pulse Oximeter (SP61) | Avita Corporation |
| 2026-02-17 | K252805 | YUWELL Finger Pulse Oximeter (YX105/YX106/YX110/YX310) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. |
| 2026-01-07 | K253109 | Reusable SpO2 Sensor (BSA307-47/BSA109-50/BSA109-31O) | Shenzhen Best Electronics Co., Ltd. |
| 2025-12-19 | K251751 | SpO2 Sensor CSS032D | Shenzhen Ykd Technology Co., Ltd. |
| 2025-09-25 | K250837 | Pulse Oximeter | Shanghai Berry Electronic Tech Co., Ltd. |
| 2025-05-09 | K241086 | Avidhrt Sense SpO2 | Avidhrt, Inc. |
| 2025-02-28 | K242876 | Pulse Oximeter (PO2/PO2A/PO2B) | Shenzhen Viatom Technology Co., Ltd. |
The recent set includes both complete pulse-oximeter systems and accessory sensors/modules, so the most suitable comparator depends on whether your research concerns a fingertip device, wearable/ring, bedside system, sensor, or oximetry module. The database’s FDA imports may lag official FDA postings; confirm time-critical details through the official FDA link on each record.
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