Cleared Traditional

K103578 - PHILIPS NM3 RESPIRATORY MONITOR WITH VE...

K103578 is an FDA 510(k) clearance for PHILIPS NM3 RESPIRATORY MONITOR WITH VE..., manufactured by Respironics Novametrix, LLC. The device is a Class 2 Anesthesiology device with product code BZK cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K103578 · Respironics Novametrix, LLC · Anesthesiology device
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Jun 2011
Decision
178d
Days
Class 2
Risk

K103578 is an FDA 510(k) clearance for the PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST. Classified as Spirometer, Monitoring (w/wo Alarm) (product code BZK), Class II - Special Controls.

Submitted by Respironics Novametrix, LLC (Wallingford, US). The FDA issued a Cleared decision on June 2, 2011 after a review of 178 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1850 - 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 Respironics Novametrix, LLC devices

FDA 510(k) Submission Details - K103578

510(k) Number K103578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2010
Decision Date June 02, 2011
Days to Decision 178 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
38d slower than avg
Panel avg: 140d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZK Device Classification - Class 2, Special Controls

Product Code BZK Spirometer, Monitoring (w/wo Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1850
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.

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All 29
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