Cleared Traditional

K042916 - WATCH PAT 100S

K042916 is an FDA 510(k) clearance for WATCH PAT 100S, manufactured by Itamar Medical. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K042916 · Itamar Medical · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
69d
Days
Class 2
Risk

K042916 is an FDA 510(k) clearance for the WATCH PAT 100S. 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 December 29, 2004 after a review of 69 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K042916

510(k) Number K042916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2004
Decision Date December 29, 2004
Days to Decision 69 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
71d faster than avg
Panel avg: 140d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K042916.
STARDUST II
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K051313 · Salter Labs · Sep 2005
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UNIVERSAL XACTTRACE
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APNEA RISK EVALUATION SYSTEM (ARES)
K041662 · Advanced Brain Monitoring, Inc. · Oct 2004
SLEEPSENSE SLEEP SENSORS
K042253 · S.L.P. , Ltd. · Oct 2004