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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 / September 2025 / K250460

510(k) cleared

WatchPAT400 (WP400)

Itamar Medical , Ltd. · Sep 5, 2025 · K250460

FDA cleared the WatchPAT400 (WP400) from Itamar Medical , Ltd. on Sep 5, 2025 under K250460, 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 Feb 18, 2025. The decision came 199 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Itamar Medical , Ltd. has one other decision in the tracker over the last 12 months: K254042 (WatchPAT SW).

Questions & Answers

What did FDA clear under K250460?

K250460 is the FDA 510(k) for WatchPAT400 (WP400), submitted by Itamar Medical , Ltd.. FDA's decision date was Sep 5, 2025, under product code MNR (Ventilatory Effort Recorder).

Who makes the WatchPAT400 (WP400)?

Itamar Medical , Ltd., based in Caesarea, is the applicant of record for K250460.

How long did the K250460 review take?

FDA received the submission on Feb 18, 2025 and issued its decision on Sep 5, 2025, 199 days later.

← All decisions in September 2025

Sources