Cleared Traditional

K254042 - WatchPAT SW

K254042 is an FDA 510(k) clearance for WatchPAT SW, manufactured by Itamar Medical , Ltd.. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K254042 · Itamar Medical , Ltd. · Anesthesiology device
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Jul 2026
Decision
227d
Days
Class 2
Risk

K254042 is an FDA 510(k) clearance for the WatchPAT SW. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Itamar Medical , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on July 31, 2026 after a review of 227 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Itamar Medical , Ltd. devices

FDA 510(k) Submission Details - K254042

510(k) Number K254042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2025
Decision Date July 31, 2026
Days to Decision 227 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 140d · This submission: 227d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNR Device Classification - Class 2, Special Controls

Product Code MNR Ventilatory Effort Recorder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.