Cleared Traditional

K133859 - WATCH-PAT200U (WP200U)

K133859 is an FDA 510(k) clearance for WATCH-PAT200U (WP200U), 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 162-day FDA review.

K133859 · Itamar Medical , Ltd. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
May 2014
Decision
162d
Days
Class 2
Risk

K133859 is an FDA 510(k) clearance for the WATCH-PAT200U (WP200U). Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Itamar Medical , Ltd. (Washington, US). The FDA issued a Cleared decision on May 30, 2014 after a review of 162 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 - K133859

510(k) Number K133859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2013
Decision Date May 30, 2014
Days to Decision 162 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
22d slower than avg
Panel avg: 140d · This submission: 162d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Anesthesiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00881829 Unknown Observational

Hypoxia Blood Validation in Multiple Pulse Oximeters

Accuracy Validation in Multiple SpO2 Systems

500
Patients (est.)
1
Site
Condition studied Hypoxia
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator David Ransom, MD
Sponsor Clinimark, LLC
Started 2016-08-09 → Primary completion 2021-12-21
Primary outcome
Completion of study by all subjects
View full study on ClinicalTrials.gov

Regulatory Peers - MNR Ventilatory Effort Recorder

All 151
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