Cleared Traditional

K970507 - PEAK FLOW METER

K970507 is an FDA 510(k) clearance for PEAK FLOW METER, manufactured by Intl. Medical, Inc.. The device is a Class 2 Anesthesiology device with product code BZH cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K970507 · Intl. Medical, Inc. · Anesthesiology device
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Jun 1997
Decision
123d
Days
Class 2
Risk

K970507 is an FDA 510(k) clearance for the PEAK FLOW METER. Classified as Meter, Peak Flow, Spirometry (product code BZH), Class II - Special Controls.

Submitted by Intl. Medical, Inc. (Burnsville, US). The FDA issued a Cleared decision on June 13, 1997 after a review of 123 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 Intl. Medical, Inc. devices

FDA 510(k) Submission Details - K970507

510(k) Number K970507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1997
Decision Date June 13, 1997
Days to Decision 123 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 140d · This submission: 123d
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 29
Devices cleared under the same product code (BZH) and FDA review panel - the closest regulatory comparables to K970507.
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