Cleared Traditional

K963089 - TRUZONE PEAK FLOW METER

K963089 is an FDA 510(k) clearance for TRUZONE PEAK FLOW METER, manufactured by Monaghan Medical Corp.. The device is a Class 2 Anesthesiology device with product code BZH cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K963089 · Monaghan Medical Corp. · Anesthesiology device
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Nov 1996
Decision
90d
Days
Class 2
Risk

K963089 is an FDA 510(k) clearance for the TRUZONE PEAK FLOW METER. Classified as Meter, Peak Flow, Spirometry (product code BZH), Class II - Special Controls.

Submitted by Monaghan Medical Corp. (Plattsburgh, US). The FDA issued a Cleared decision on November 6, 1996 after a review of 90 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 Monaghan Medical Corp. devices

FDA 510(k) Submission Details - K963089

510(k) Number K963089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1996
Decision Date November 06, 1996
Days to Decision 90 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
50d faster than avg
Panel avg: 140d · This submission: 90d
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 K963089.
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
TRUPEAK PEAK FLOW METER
K963095 · Monaghan Medical Corp. · Nov 1996
TRUPEAK PEAK FLOW METER
K955234 · Monaghan Medical Corp. · Mar 1996
TRUZONE PEAK FLOW METER
K955262 · Monaghan Medical Corp. · Mar 1996