Cleared Traditional

K092335 - PEAK EXPIRATORY FLOW METER, KN-9710

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

K092335 · K-Jump Health Co., Ltd. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K092335

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
Combination Product No
PCCP Authorized No
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.

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 80
Devices cleared under the same product code (BZH) and FDA review panel - the closest regulatory comparables to K092335.
MSA100 PEAK FLOW METER
K133975 · Beijing M&B Electronic Instruments Co., Ltd. · Oct 2014
STRIVE DUAL ZONE PEAK FLOW METER
K123945 · Monaghan Medical Corp. · Apr 2013
RXPEAKFLOW
K101380 · Noble Marketing · Sep 2010
CLEAN PEAK FLOW METER
K091412 · Viasys Healthcare GmbH · Aug 2009
DYNAMIPEAK PEAK FLOW METER
K082899 · Dynamitech Medical, Inc. · Mar 2009
MINI-WRIGHT DIGITAL, MODEL 3120001
K053156 · Clement Clarke Intl., Ltd. · Jan 2006
K092335 · PEAK EXPIRATORY FLOW METER, KN-9710
Download PDF FDA Summary K-Jump Health Co., Lt…