Cleared Abbreviated

K040723 - MICROLIFE ELECTRONIC PEAK FLOW MONITOR

K040723 is an FDA 510(k) clearance for MICROLIFE ELECTRONIC PEAK FLOW MONITOR, manufactured by Microlife Intellectual Property GmbH. The device is a Class 2 Anesthesiology device with product code BZH cleared through the Abbreviated 510(k) pathway after a 80-day FDA review.

K040723 · Microlife Intellectual Property GmbH · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
80d
Days
Class 2
Risk

K040723 is an FDA 510(k) clearance for the MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITH PEF AND FEV1, MODELS PF-100 AND .... Classified as Meter, Peak Flow, Spirometry (product code BZH), Class II - Special Controls.

Submitted by Microlife Intellectual Property GmbH (Great Neck, US). The FDA issued a Cleared decision on June 10, 2004 after a review of 80 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. 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 Microlife Intellectual Property GmbH devices

FDA 510(k) Submission Details - K040723

510(k) Number K040723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2004
Decision Date June 10, 2004
Days to Decision 80 days
Submission Type Abbreviated
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
60d faster than avg
Panel avg: 140d · This submission: 80d
Pathway characteristics
Standards-based clearance path.

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 K040723.
STRIVE DUAL ZONE PEAK FLOW METER
K123945 · Monaghan Medical Corp. · Apr 2013
PEAK EXPIRATORY FLOW METER, KN-9710
K092335 · K-Jump Health Co., Ltd. · Apr 2010
PMP4 SPIROPRO
K050853 · Card Guard Scientific Survival , Ltd. · May 2005
MODIFICATION TO TRUPEAK PEAK FLOW METER
K031514 · Monaghan Medical Corp. · May 2003
TRUEZONE PEAK FLOW METER
K023097 · Monaghan Medical Corp. · Mar 2003
MODIFICATION TO TRUZONE PEAK FLOW METER
K991212 · Monaghan Medical Corp. · Jul 1999