Cleared Traditional

Spo2 Sensor CSS032D

K251751 · Shenzhen Ykd Technology Co., Ltd. · Anesthesiology
Dec 2025
Decision
193d
Days
Class 2
Risk

About This 510(k) Submission

K251751 is an FDA 510(k) clearance for the Spo2 Sensor CSS032D, 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 review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K251751 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code DQA — Oximeter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2700

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