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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 / June 2026 / K261634

510(k) cleared

Disposable Blood Lancet (Soft)

SteriLance Medical (Suzhou), Inc. · Jun 12, 2026 · K261634

FDA cleared the Disposable Blood Lancet (Soft) from SteriLance Medical (Suzhou), Inc. on Jun 12, 2026 under K261634, a special 510(k). The device falls under product code QRK, Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature, 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 May 18, 2026. The decision came 25 days later, inside the 90 FDA-day goal for a 510(k).

SteriLance Medical (Suzhou), Inc. has one other decision in the tracker over the last 12 months: K260122 (Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)).

Questions & Answers

What did FDA clear under K261634?

K261634 is the FDA 510(k) for Disposable Blood Lancet (Soft), submitted by SteriLance Medical (Suzhou), Inc.. FDA's decision date was Jun 12, 2026, under product code QRK (Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature).

Who makes the Disposable Blood Lancet (Soft)?

SteriLance Medical (Suzhou), Inc., based in Suzhou, is the applicant of record for K261634.

How long did the K261634 review take?

FDA received the submission on May 18, 2026 and issued its decision on Jun 12, 2026, 25 days later.

← All decisions in June 2026

Sources