Cleared Traditional

K934502 - FLOW SPIROMETER

K934502 is an FDA 510(k) clearance for FLOW SPIROMETER, manufactured by Healthdyne, Inc.. The device is a Class 2 Anesthesiology device with product code BZH cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K934502 · Healthdyne, Inc. · Anesthesiology device
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Apr 1994
Decision
202d
Days
Class 2
Risk

K934502 is an FDA 510(k) clearance for the FLOW SPIROMETER. Classified as Meter, Peak Flow, Spirometry (product code BZH), Class II - Special Controls.

Submitted by Healthdyne, Inc. (Marietta, US). The FDA issued a Cleared decision on April 4, 1994 after a review of 202 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 - K934502

510(k) Number K934502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1993
Decision Date April 04, 1994
Days to Decision 202 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
62d slower than avg
Panel avg: 140d · This submission: 202d
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 69
Devices cleared under the same product code (BZH) and FDA review panel - the closest regulatory comparables to K934502.
PEAKLOG AND DISPLAY SOFTWARE
K940835 · Medtrac Technologies Corp. · Nov 1994
PEAKLOG AND DISPLAY SOFTWARE
K940836 · Tamarac Systems Corp. · Nov 1994
FLOW=MED
K924322 · International Electronic Technology Corp. · Apr 1994
PERSONAL BEST LOW RANGE
K933889 · Healthscan Products, Inc. · Sep 1993
PEAK FLOW METER
K926307 · Monaghan Medical Corp. · Jul 1993
WRIGHT POCKET PEAK FLOW METER
K924343 · Ferraris Medical, Inc. · Jun 1993
K934502 · FLOW SPIROMETER
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