Cleared Special

K081037 - WATCH-PAT 200I (WP200I)

K081037 is an FDA 510(k) clearance for WATCH-PAT 200I (WP200I), manufactured by Itamar Medical. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Special 510(k) pathway after a 59-day FDA review.

K081037 · Itamar Medical · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
59d
Days
Class 2
Risk

K081037 is an FDA 510(k) clearance for the WATCH-PAT 200I (WP200I). Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Itamar Medical (Washington, US). The FDA issued a Cleared decision on June 9, 2008 after a review of 59 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.

FDA 510(k) Submission Details - K081037

510(k) Number K081037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2008
Decision Date June 09, 2008
Days to Decision 59 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
81d faster than avg
Panel avg: 140d · This submission: 59d
Pathway characteristics
Modification to existing cleared device.

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.

Regulatory Peers - MNR Ventilatory Effort Recorder

All 162
Devices cleared under the same product code (MNR) and FDA review panel - the closest regulatory comparables to K081037.
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SNAP MODEL 7 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM
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K080427 · Itamar Medical · May 2008
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K073269 · Hypnocore, Ltd. · Apr 2008