Cleared Traditional

K092335 - PEAK EXPIRATORY FLOW METER

K092335 is the FDA 510(k) clearance for PEAK EXPIRATORY FLOW METER by K-Jump Health Co., Ltd.. It is a Class 2 Anesthesiology device (product code BZH) cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K092335 · K-Jump Health Co., Ltd. · Anesthesiology device
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Apr 2010
Decision
248d
Days
Class 2
Risk

K092335 is an FDA 510(k) clearance for the PEAK EXPIRATORY FLOW METER, KN-9710. Classified as Meter, Peak Flow, Spirometry (product code BZH), Class II - Special Controls.

Submitted by K-Jump Health Co., Ltd. (Taipei Hsien, TW). The FDA issued a Cleared decision on April 9, 2010 after a review of 248 days - an extended review cycle.

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 K-Jump Health Co., Ltd. devices

Submission Details

510(k) Number K092335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2009
Decision Date April 09, 2010
Days to Decision 248 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 140d · This submission: 248d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Peers - BZH Meter, Peak Flow, Spirometry

All 16
Devices cleared under the same product code (BZH) and FDA review panel - the closest regulatory comparables to K092335.
Peak.me
K180487 · Breathe Me, Ltd. · Oct 2018
Smart One
K181666 · Mir Medical International Research · Aug 2018
Besmed Peak Flow Meter
K172804 · Besmed Health Business Corp · Jan 2018
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
CARD GUARD
K934795 · Card Guard Scientific Survival , Ltd. · Apr 1995