WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / K252628

510(k) cleared

CASSIE

Wesper, Inc. · Apr 27, 2026 · K252628

FDA cleared the CASSIE from Wesper, Inc. on Apr 27, 2026 under K252628, a traditional 510(k). The device falls under product code MNR, Ventilatory Effort Recorder, regulated at 21 CFR 868.2375 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Aug 20, 2025. The decision came 250 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 Wesper, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252628?

K252628 is the FDA 510(k) for CASSIE, submitted by Wesper, Inc.. FDA's decision date was Apr 27, 2026, under product code MNR (Ventilatory Effort Recorder).

Who makes the CASSIE?

Wesper, Inc., based in Long Island City, NY, is the applicant of record for K252628.

How long did the K252628 review take?

FDA received the submission on Aug 20, 2025 and issued its decision on Apr 27, 2026, 250 days later.

← All decisions in April 2026