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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 / K253769

510(k) cleared

Instylla Delivery Kit

Instylla, Inc. · Dec 22, 2025 · K253769

FDA cleared the Instylla Delivery Kit from Instylla, Inc. on Dec 22, 2025 under K253769, a special 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 Nov 25, 2025. The decision came 27 days later, inside the 90 FDA-day goal for a 510(k).

Instylla, Inc. has 2 other decisions in the tracker over the last 12 months: K261610 (Verge Microcatheter), K253677 (Tembo Embolic System).

Questions & Answers

What did FDA clear under K253769?

K253769 is the FDA 510(k) for Instylla Delivery Kit, submitted by Instylla, Inc.. FDA's decision date was Dec 22, 2025, under product code FMF (Syringe, Piston).

Who makes the Instylla Delivery Kit?

Instylla, Inc., based in Bedford, MA, is the applicant of record for K253769.

How long did the K253769 review take?

FDA received the submission on Nov 25, 2025 and issued its decision on Dec 22, 2025, 27 days later.

← All decisions in December 2025

Sources