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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 / December 2025 / K250192

510(k) cleared

Verisafe Safety Retractable Insulin Syringes

Promisemed Hangzhou Meditech Co., Ltd. · Dec 10, 2025 · K250192

FDA cleared the Verisafe Safety Retractable Insulin Syringes from Promisemed Hangzhou Meditech Co., Ltd. on Dec 10, 2025 under K250192, 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 Jan 23, 2025. The decision came 321 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), K254273 (Verisafe Safety Sterile Needles (SSN)).

Questions & Answers

What did FDA clear under K250192?

K250192 is the FDA 510(k) for Verisafe Safety Retractable Insulin Syringes, submitted by Promisemed Hangzhou Meditech Co., Ltd.. FDA's decision date was Dec 10, 2025, under product code FMF (Syringe, Piston).

Who makes the Verisafe Safety Retractable Insulin Syringes?

Promisemed Hangzhou Meditech Co., Ltd., based in Hangzhou City, is the applicant of record for K250192.

How long did the K250192 review take?

FDA received the submission on Jan 23, 2025 and issued its decision on Dec 10, 2025, 321 days later.

← All decisions in December 2025

Sources