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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / January 2026 / K253109

510(k) cleared

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

Shenzhen Best Electronics Co., Ltd. · Jan 7, 2026 · K253109

FDA cleared the Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) from Shenzhen Best Electronics Co., Ltd. on Jan 7, 2026 under K253109, a traditional 510(k). The device falls under product code DQA, Oximeter, regulated at 21 CFR 870.2700 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 24, 2025. The decision came 105 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Shenzhen Best Electronics Co., Ltd. has one other decision in the tracker over the last 12 months: K253089 (NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)).

Questions & Answers

What did FDA clear under K253109?

K253109 is the FDA 510(k) for Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O), submitted by Shenzhen Best Electronics Co., Ltd.. FDA's decision date was Jan 7, 2026, under product code DQA (Oximeter).

Who makes the Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)?

Shenzhen Best Electronics Co., Ltd., based in Shenzhen, is the applicant of record for K253109.

How long did the K253109 review take?

FDA received the submission on Sep 24, 2025 and issued its decision on Jan 7, 2026, 105 days later.

← All decisions in January 2026

Sources