Cleared Special

K031514 - MODIFICATION TO TRUPEAK PEAK FLOW METER

K031514 is an FDA 510(k) clearance for MODIFICATION TO TRUPEAK PEAK FLOW METER, manufactured by Monaghan Medical Corp.. The device is a Class 2 Anesthesiology device with product code BZH cleared through the Special 510(k) pathway after a 9-day FDA review.

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

FDA 510(k) Submission Details - K031514

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
131d faster than avg
Panel avg: 140d · This submission: 9d
Pathway characteristics
Modification to existing cleared device.

BZH Device Classification - Class 2, Special Controls

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.

Regulatory Peers - BZH Meter, Peak Flow, Spirometry

All 26
Devices cleared under the same product code (BZH) and FDA review panel - the closest regulatory comparables to K031514.
PEAK EXPIRATORY FLOW METER, KN-9710
K092335 · K-Jump Health Co., Ltd. · Apr 2010
PMP4 SPIROPRO
K050853 · Card Guard Scientific Survival , Ltd. · May 2005
MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITH PEF AND FEV1, MODELS PF-100 AND PF-100-1 (WITH SOFTWARE)
K040723 · Microlife Intellectual Property GmbH · Jun 2004
TRUEZONE PEAK FLOW METER
K023097 · Monaghan Medical Corp. · Mar 2003
MODIFICATION TO TRUZONE PEAK FLOW METER
K991212 · Monaghan Medical Corp. · Jul 1999
AEROGEAR ASTHMA ACTION KIT
K964130 · Monaghan Medical Corp. · Jan 1997