Cleared Traditional

K982334 - AIRZONE PEAK FLOWMETER

K982334 is an FDA 510(k) clearance for AIRZONE PEAK FLOWMETER, manufactured by Clement Clarke Intl., Ltd.. The device is a Class 2 Anesthesiology device with product code BZH cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K982334 · Clement Clarke Intl., Ltd. · Anesthesiology device
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Jan 1999
Decision
196d
Days
Class 2
Risk

K982334 is an FDA 510(k) clearance for the AIRZONE PEAK FLOWMETER. Classified as Meter, Peak Flow, Spirometry (product code BZH), Class II - Special Controls.

Submitted by Clement Clarke Intl., Ltd. (Harlow, GB). The FDA issued a Cleared decision on January 14, 1999 after a review of 196 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 Clement Clarke Intl., Ltd. devices

FDA 510(k) Submission Details - K982334

510(k) Number K982334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1998
Decision Date January 14, 1999
Days to Decision 196 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 140d · This submission: 196d
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 27
Devices cleared under the same product code (BZH) and FDA review panel - the closest regulatory comparables to K982334.
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
AEROGEAR ASTHMA ACTION KIT
K964130 · Monaghan Medical Corp. · Jan 1997
TRUZONE PEAK FLOW METER
K963089 · Monaghan Medical Corp. · Nov 1996
TRUPEAK PEAK FLOW METER
K963095 · Monaghan Medical Corp. · Nov 1996