Cleared Special

K031514 - MODIFICATION TO TRUPEAK PEAK FLOW METER (FDA 510(k) Clearance)

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

K031514 · Monaghan Medical Corp. · Anesthesiology device
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May 2003
Decision
9d
Days
Class 2
Risk

K031514 is an FDA 510(k) clearance for the MODIFICATION TO TRUPEAK PEAK FLOW METER. Classified as Meter, Peak Flow, Spirometry (product code BZH), Class II - Special Controls.

Submitted by Monaghan Medical Corp. (Plattsburgh, US). The FDA issued a Cleared decision on May 23, 2003 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1860 - 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.

View all Monaghan Medical Corp. devices

Submission Details

510(k) Number K031514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2003
Decision Date May 23, 2003
Days to Decision 9 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
130d faster than avg
Panel avg: 139d · This submission: 9d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code BZH Meter, Peak Flow, Spirometry
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1860
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.