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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 / April 2026 / K253107

510(k) cleared

Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)

Shenzhen Dongjiang Technology Co., Ltd. · Apr 14, 2026 · K253107

FDA cleared the Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90) from Shenzhen Dongjiang Technology Co., Ltd. on Apr 14, 2026 under K253107, a traditional 510(k). The device falls under product code BTA, Pump, Portable, Aspiration (Manual Or Powered), regulated at 21 CFR 878.4780 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Sep 24, 2025. The decision came 202 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Shenzhen Dongjiang Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253107?

K253107 is the FDA 510(k) for Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90), submitted by Shenzhen Dongjiang Technology Co., Ltd.. FDA's decision date was Apr 14, 2026, under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)).

Who makes the Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)?

Shenzhen Dongjiang Technology Co., Ltd., based in Shenzhen, is the applicant of record for K253107.

How long did the K253107 review take?

FDA received the submission on Sep 24, 2025 and issued its decision on Apr 14, 2026, 202 days later.

← All decisions in April 2026