Cleared Traditional

K203839 - WatchPAT200U (WP200U) (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence.

K203839 · Itamar Medical , Ltd. · Anesthesiology device
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Mar 2022
Decision
446d
Days
Class 2
Risk

K203839 is an FDA 510(k) clearance for the WatchPAT200U (WP200U). 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 March 21, 2022 after a review of 446 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Itamar Medical , Ltd. devices

Submission Details

510(k) Number K203839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2020
Decision Date March 21, 2022
Days to Decision 446 days
Submission Type Traditional
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
307d slower than avg
Panel avg: 139d · This submission: 446d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. 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.

Clinical Evidence

ClinicalTrials.gov
NCT01570738 Completed Observational Industry-sponsored

Validation of Home Sleep Testing (WP) Compared to an Overnight Sleep Testing in the Sleep Laboratory

274
Patients (actual)
1
Site
Condition studied Sleep Disorders
Eligibility All sexes · 5 Years+ · Healthy volunteers accepted
Sponsor Itamar-Medical, Israel (industry)
Started 2012-07-01 → Primary completion 2022-06-01
Primary outcome
Compare sleep data collected from the Watch-PAT device to PSG data
Study completed - no results published. This trial concluded in 2022 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov