Cleared Traditional

K961779 - MINI-BELL PEAK FLOW METER/LOW RANGE MODEL PEAK FLOW METER (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K961779 · Avion Medical Products, Inc. · Anesthesiology device
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Jun 1997
Decision
401d
Days
Class 2
Risk

K961779 is an FDA 510(k) clearance for the MINI-BELL PEAK FLOW METER/LOW RANGE MODEL PEAK FLOW METER. Classified as Meter, Peak Flow, Spirometry (product code BZH), Class II - Special Controls.

Submitted by Avion Medical Products, Inc. (Burlington, Ontario, CA). The FDA issued a Cleared decision on June 13, 1997 after a review of 401 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Avion Medical Products, Inc. devices

Submission Details

510(k) Number K961779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1996
Decision Date June 13, 1997
Days to Decision 401 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
262d slower than avg
Panel avg: 139d · This submission: 401d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 78
Devices cleared under the same product code (BZH) and FDA review panel - the closest regulatory comparables to K961779.
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