Cleared Traditional

WatchPAT400 (WP400)

K250460 · Itamar Medical , Ltd. · Anesthesiology
Sep 2025
Decision
199d
Days
Class 2
Risk

About This 510(k) Submission

K250460 is an FDA 510(k) clearance for the WatchPAT400 (WP400), a Ventilatory Effort Recorder (Class II — Special Controls, product code MNR), submitted by Itamar Medical , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on September 5, 2025, 199 days after receiving the submission on February 18, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number K250460 FDA.gov
FDA Decision Cleared SESE
Date Received February 18, 2025
Decision Date September 05, 2025
Days to Decision 199 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code MNR — Ventilatory Effort Recorder
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.2375