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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 / April 2026 / K254273

510(k) cleared

Verisafe Safety Sterile Needles (SSN)

Promisemed Hangzhou Meditech Co., Ltd. · Apr 16, 2026 · K254273

FDA cleared the Verisafe Safety Sterile Needles (SSN) from Promisemed Hangzhou Meditech Co., Ltd. on Apr 16, 2026 under K254273, a special 510(k). The device falls under product code FMI, Needle, Hypodermic, Single Lumen, regulated at 21 CFR 880.5570 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Dec 30, 2025. The decision came 107 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Promisemed Hangzhou Meditech Co., Ltd. has 3 other decisions in the tracker over the last 12 months: K261196 (Promisemed VeriEcto Automatic Biopsy Needles), K261045 (Verifine Safety Lancets), K250192 (Verisafe Safety Retractable Insulin Syringes).

Questions & Answers

What did FDA clear under K254273?

K254273 is the FDA 510(k) for Verisafe Safety Sterile Needles (SSN), submitted by Promisemed Hangzhou Meditech Co., Ltd.. FDA's decision date was Apr 16, 2026, under product code FMI (Needle, Hypodermic, Single Lumen).

Who makes the Verisafe Safety Sterile Needles (SSN)?

Promisemed Hangzhou Meditech Co., Ltd., based in Hangzhou City, is the applicant of record for K254273.

How long did the K254273 review take?

FDA received the submission on Dec 30, 2025 and issued its decision on Apr 16, 2026, 107 days later.

← All decisions in April 2026

Sources