Cleared Abbreviated

K032403 - SMARTMONITOR 2 PROFESSIONAL SERIES (PS) (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K032403 · Respironics, Inc. · Anesthesiology device
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Oct 2003
Decision
84d
Days
Class 2
Risk

K032403 is an FDA 510(k) clearance for the SMARTMONITOR 2 PROFESSIONAL SERIES (PS). Classified as Monitor, Apnea, Home Use (product code NPF), Class II - Special Controls.

Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on October 27, 2003 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2377 - the FDA anesthesiology and respiratory device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Respironics, Inc. devices

Submission Details

510(k) Number K032403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2003
Decision Date October 27, 2003
Days to Decision 84 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 139d · This submission: 84d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code NPF Monitor, Apnea, Home Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2377
Definition Same As The Identification For Product Code Fls, Just Add Home Use
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.