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 / February 2026 / K253605

510(k) cleared

Safety Heel Lancet

Ningbo Medsun Medical Co., Ltd. · Feb 20, 2026 · K253605

FDA cleared the Safety Heel Lancet from Ningbo Medsun Medical Co., Ltd. on Feb 20, 2026 under K253605, a traditional 510(k). The device falls under product code FMK, Single Use Only Blood Lancet With 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 Nov 18, 2025. The decision came 94 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Ningbo Medsun Medical Co., Ltd. has one other decision in the tracker over the last 12 months: K253622 (Safety Pen Needle).

Questions & Answers

What did FDA clear under K253605?

K253605 is the FDA 510(k) for Safety Heel Lancet, submitted by Ningbo Medsun Medical Co., Ltd.. FDA's decision date was Feb 20, 2026, under product code FMK (Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature).

Who makes the Safety Heel Lancet?

Ningbo Medsun Medical Co., Ltd., based in Ningbo, is the applicant of record for K253605.

How long did the K253605 review take?

FDA received the submission on Nov 18, 2025 and issued its decision on Feb 20, 2026, 94 days later.

← All decisions in February 2026

Sources