Cleared Traditional

Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)

K253109 · Shenzhen Best Electronics Co., Ltd. · Anesthesiology
Jan 2026
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K253109 is an FDA 510(k) clearance for the Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O), a Oximeter (Class II — Special Controls, product code DQA), submitted by Shenzhen Best Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 7, 2026, 105 days after receiving the submission on September 24, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K253109 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 2025
Decision Date January 07, 2026
Days to Decision 105 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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