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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 / August 2026 / K253747

510(k) cleared

Disposable Pen Injector (KXYC-03C02, KXYC-03A03)

Jiangsu Enjosim Medical Technology Co., Ltd. · Aug 14, 2026 · K253747

FDA cleared the Disposable Pen Injector (KXYC-03C02, KXYC-03A03) from Jiangsu Enjosim Medical Technology Co., Ltd. on Aug 14, 2026 under K253747, a traditional 510(k). The device falls under product code FMF, Syringe, Piston, regulated at 21 CFR 880.5860 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Nov 25, 2025. The decision came 262 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 Jiangsu Enjosim Medical Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253747?

K253747 is the FDA 510(k) for Disposable Pen Injector (KXYC-03C02, KXYC-03A03), submitted by Jiangsu Enjosim Medical Technology Co., Ltd.. FDA's decision date was Aug 14, 2026, under product code FMF (Syringe, Piston).

Who makes the Disposable Pen Injector (KXYC-03C02, KXYC-03A03)?

Jiangsu Enjosim Medical Technology Co., Ltd., based in Wu Xi, is the applicant of record for K253747.

How long did the K253747 review take?

FDA received the submission on Nov 25, 2025 and issued its decision on Aug 14, 2026, 262 days later.

← All decisions in August 2026