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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 / July 2026 / K260122

510(k) cleared

Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)

SteriLance Medical (Suzhou), Inc. · Jul 6, 2026 · K260122

FDA cleared the Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep) from SteriLance Medical (Suzhou), Inc. on Jul 6, 2026 under K260122, a traditional 510(k). The device falls under product code QRL, Multiple Use Blood Lancet For Single Patient Use Only, regulated at 21 CFR 878.4850 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jan 15, 2026. The decision came 172 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

SteriLance Medical (Suzhou), Inc. has one other decision in the tracker over the last 12 months: K261634 (Disposable Blood Lancet (Soft)).

Questions & Answers

What did FDA clear under K260122?

K260122 is the FDA 510(k) for Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep), submitted by SteriLance Medical (Suzhou), Inc.. FDA's decision date was Jul 6, 2026, under product code QRL (Multiple Use Blood Lancet For Single Patient Use Only).

Who makes the Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)?

SteriLance Medical (Suzhou), Inc., based in Suzhou, is the applicant of record for K260122.

How long did the K260122 review take?

FDA received the submission on Jan 15, 2026 and issued its decision on Jul 6, 2026, 172 days later.

← All decisions in July 2026

Sources