Cleared Traditional

K172804 - Besmed Peak Flow Meter

K172804 is an FDA 510(k) clearance for Besmed Peak Flow Meter, manufactured by Besmed Health Business Corp. The device is a Class 2 Anesthesiology device with product code BZH cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K172804 · Besmed Health Business Corp · Anesthesiology device
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Jan 2018
Decision
115d
Days
Class 2
Risk

K172804 is an FDA 510(k) clearance for the Besmed Peak Flow Meter. Classified as Meter, Peak Flow, Spirometry (product code BZH), Class II - Special Controls.

Submitted by Besmed Health Business Corp (Wu-Ku District, TW). The FDA issued a Cleared decision on January 11, 2018 after a review of 115 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Besmed Health Business Corp devices

FDA 510(k) Submission Details - K172804

510(k) Number K172804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2017
Decision Date January 11, 2018
Days to Decision 115 days
Submission Type Traditional
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
25d faster than avg
Panel avg: 140d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K172804.
Smart Peak Flow Meter
K191239 · Guangzhou Homesun Medical Technology Co., Ltd. · Dec 2019
Peak.me
K180487 · Breathe Me, Ltd. · Oct 2018
Smart One
K181666 · Mir Medical International Research · Aug 2018
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