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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 / June 2026 / K253404

510(k) cleared

CLEAR Aspiration System

Insera Therapeutics, Inc. · Jun 24, 2026 · K253404

FDA cleared the CLEAR Aspiration System from Insera Therapeutics, Inc. on Jun 24, 2026 under K253404, a traditional 510(k). The review panel was Unknown.

FDA logged the submission as received on Sep 30, 2025. The decision came 267 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Insera Therapeutics, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253404?

K253404 is the FDA 510(k) for CLEAR Aspiration System, submitted by Insera Therapeutics, Inc.. FDA's decision date was Jun 24, 2026.

Who makes the CLEAR Aspiration System?

Insera Therapeutics, Inc., based in Dallas, TX, is the applicant of record for K253404.

How long did the K253404 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Jun 24, 2026, 267 days later.

← All decisions in June 2026