Cleared Traditional

K010739 - WATCH-PAT 100 (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K010739 · Itamar Medical (C.M.) 1997 , Ltd. · Anesthesiology device
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Nov 2001
Decision
239d
Days
Class 2
Risk

K010739 is an FDA 510(k) clearance for the WATCH-PAT 100. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Itamar Medical (C.M.) 1997 , Ltd. (Hasbrouck Heights, US). The FDA issued a Cleared decision on November 6, 2001 after a review of 239 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 (C.M.) 1997 , Ltd. devices

Submission Details

510(k) Number K010739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2001
Decision Date November 06, 2001
Days to Decision 239 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
100d slower than avg
Panel avg: 139d · This submission: 239d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.