WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / March 2026 / K260147

510(k) cleared

Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)

Shenzhen Kingboom Technology Co., Ltd. · Mar 13, 2026 · K260147

FDA cleared the Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036) from Shenzhen Kingboom Technology Co., Ltd. on Mar 13, 2026 under K260147, 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 Jan 20, 2026. The decision came 52 days later, inside the 90 FDA-day goal for a 510(k).

Shenzhen Kingboom Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K260473 (Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)).

Questions & Answers

What did FDA clear under K260147?

K260147 is the FDA 510(k) for Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036), submitted by Shenzhen Kingboom Technology Co., Ltd.. FDA's decision date was Mar 13, 2026, under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)).

Who makes the Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)?

Shenzhen Kingboom Technology Co., Ltd., based in Shenzhen, is the applicant of record for K260147.

How long did the K260147 review take?

FDA received the submission on Jan 20, 2026 and issued its decision on Mar 13, 2026, 52 days later.

← All decisions in March 2026

Sources