Cleared Special

K222331 - WatchPAT300 (WP300) (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K222331 · Itamar Medical , Ltd. · Anesthesiology device
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Sep 2022
Decision
43d
Days
Class 2
Risk

K222331 is an FDA 510(k) clearance for the WatchPAT300 (WP300). 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 September 14, 2022 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Itamar Medical , Ltd. devices

Submission Details

510(k) Number K222331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2022
Decision Date September 14, 2022
Days to Decision 43 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 139d · This submission: 43d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.

Regulatory Consultant

Hogan Lovells US LLP
Jonathan Kahan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.