Cleared Special

K091459 - PHILIPS NM3 MONITOR, MODEL 7900

K091459 is an FDA 510(k) clearance for PHILIPS NM3 MONITOR, manufactured by Respironics Novametrix, LLC. The device is a Class 2 Anesthesiology device with product code BZK cleared through the Special 510(k) pathway after a 71-day FDA review.

K091459 · Respironics Novametrix, LLC · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
71d
Days
Class 2
Risk

K091459 is an FDA 510(k) clearance for the PHILIPS NM3 MONITOR, MODEL 7900. 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 July 28, 2009 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1850 - 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 - K091459

510(k) Number K091459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2009
Decision Date July 28, 2009
Days to Decision 71 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
69d faster than avg
Panel avg: 140d · This submission: 71d
Pathway characteristics
Modification to existing cleared device.

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.

Regulatory Peers - BZK Spirometer, Monitoring (w/wo Alarm)

All 38
Devices cleared under the same product code (BZK) and FDA review panel - the closest regulatory comparables to K091459.
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