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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 / K253677

510(k) cleared

Tembo Embolic System

Instylla, Inc. · Dec 15, 2025 · K253677

FDA cleared the Tembo Embolic System from Instylla, Inc. on Dec 15, 2025 under K253677, a special 510(k). The device falls under product code KRD, Device, Vascular, For Promoting Embolization, regulated at 21 CFR 870.3300 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Nov 21, 2025. The decision came 24 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), K253769 (Instylla Delivery Kit).

Questions & Answers

What did FDA clear under K253677?

K253677 is the FDA 510(k) for Tembo Embolic System, submitted by Instylla, Inc.. FDA's decision date was Dec 15, 2025, under product code KRD (Device, Vascular, For Promoting Embolization).

Who makes the Tembo Embolic System?

Instylla, Inc., based in Bedford, MA, is the applicant of record for K253677.

How long did the K253677 review take?

FDA received the submission on Nov 21, 2025 and issued its decision on Dec 15, 2025, 24 days later.

← All decisions in December 2025

Sources