K251751 is an FDA 510(k) clearance for the Spo2 Sensor CSS032D. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Shenzhen Ykd Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 19, 2025, 193 days after receiving the submission on June 9, 2025.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K251751 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 2025 |
| Decision Date | December 19, 2025 |
| Days to Decision | 193 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | DQA - Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |