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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 / K252279

510(k) cleared

Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)

Chirana T.Injecta,A.S. · Apr 17, 2026 · K252279

FDA cleared the Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) from Chirana T.Injecta,A.S. on Apr 17, 2026 under K252279, 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 Jul 22, 2025. The decision came 269 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Chirana T.Injecta,A.S. has one other decision in the tracker over the last 12 months: K252483 (Enteral Syringe (20ml, 60ml)).

Questions & Answers

What did FDA clear under K252279?

K252279 is the FDA 510(k) for Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml), submitted by Chirana T.Injecta,A.S.. FDA's decision date was Apr 17, 2026, under product code FMF (Syringe, Piston).

Who makes the Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)?

Chirana T.Injecta,A.S., based in Stará Turá, is the applicant of record for K252279.

How long did the K252279 review take?

FDA received the submission on Jul 22, 2025 and issued its decision on Apr 17, 2026, 269 days later.

← All decisions in April 2026

Sources