Cleared Special

K091412 - CLEAN PEAK FLOW METER

K091412 is an FDA 510(k) clearance for CLEAN PEAK FLOW METER, manufactured by Viasys Healthcare GmbH. The device is a Class 2 Anesthesiology device with product code BZH cleared through the Special 510(k) pathway after a 100-day FDA review.

K091412 · Viasys Healthcare GmbH · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
100d
Days
Class 2
Risk

K091412 is an FDA 510(k) clearance for the CLEAN PEAK FLOW METER. Classified as Meter, Peak Flow, Spirometry (product code BZH), Class II - Special Controls.

Submitted by Viasys Healthcare GmbH (Hoechberg, DE). The FDA issued a Cleared decision on August 21, 2009 after a review of 100 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K091412

510(k) Number K091412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2009
Decision Date August 21, 2009
Days to Decision 100 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
40d faster than avg
Panel avg: 140d · This submission: 100d
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 67
Devices cleared under the same product code (BZH) and FDA review panel - the closest regulatory comparables to K091412.
STRIVE DUAL ZONE PEAK FLOW METER
K123945 · Monaghan Medical Corp. · Apr 2013
RXPEAKFLOW
K101380 · Noble Marketing · Sep 2010
PEAK EXPIRATORY FLOW METER, KN-9710
K092335 · K-Jump Health Co., Ltd. · Apr 2010
DYNAMIPEAK PEAK FLOW METER
K082899 · Dynamitech Medical, Inc. · Mar 2009
MINI-WRIGHT DIGITAL, MODEL 3120001
K053156 · Clement Clarke Intl., Ltd. · Jan 2006
PMP4 SPIROPRO
K050853 · Card Guard Scientific Survival , Ltd. · May 2005