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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 / July 2026 / K252483

510(k) cleared

Enteral Syringe (20ml, 60ml)

Chirana T.Injecta,A.S. · Jul 1, 2026 · K252483

FDA cleared the Enteral Syringe (20ml, 60ml) from Chirana T.Injecta,A.S. on Jul 1, 2026 under K252483, a traditional 510(k). The device falls under product code PNR, Enteral Syringes With Enteral Specific Connectors, regulated at 21 CFR 876.5980 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Aug 7, 2025. The decision came 328 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: K252279 (Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)).

Questions & Answers

What did FDA clear under K252483?

K252483 is the FDA 510(k) for Enteral Syringe (20ml, 60ml), submitted by Chirana T.Injecta,A.S.. FDA's decision date was Jul 1, 2026, under product code PNR (Enteral Syringes With Enteral Specific Connectors).

Who makes the Enteral Syringe (20ml, 60ml)?

Chirana T.Injecta,A.S., based in Stará Turá, is the applicant of record for K252483.

How long did the K252483 review take?

FDA received the submission on Aug 7, 2025 and issued its decision on Jul 1, 2026, 328 days later.

← All decisions in July 2026

Sources