Cleared Traditional

K914126 - VMX MINI-LOG FLOWMETER

K914126 is an FDA 510(k) clearance for VMX MINI-LOG FLOWMETER, manufactured by Clement Clarke, Inc.. The device is a Class 2 Anesthesiology device with product code BZH cleared through the Traditional 510(k) pathway after a 539-day FDA review.

K914126 · Clement Clarke, Inc. · Anesthesiology device
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Mar 1993
Decision
539d
Days
Class 2
Risk

K914126 is an FDA 510(k) clearance for the VMX MINI-LOG FLOWMETER. Classified as Meter, Peak Flow, Spirometry (product code BZH), Class II - Special Controls.

Submitted by Clement Clarke, Inc. (England, GB). The FDA issued a Cleared decision on March 5, 1993 after a review of 539 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.

FDA 510(k) Submission Details - K914126

510(k) Number K914126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1991
Decision Date March 05, 1993
Days to Decision 539 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
399d slower than avg
Panel avg: 140d · This submission: 539d
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 75
Devices cleared under the same product code (BZH) and FDA review panel - the closest regulatory comparables to K914126.
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
ASTECH HOME PEAK FLOW METER
K915060 · Biotrine Corp. · Sep 1992
THE PEAK
K920390 · Multispiro, Inc. · Sep 1992
PEAK EXPIRATORY FLOW METER
K912866 · Health Products, Inc. · Aug 1992
K914126 · VMX MINI-LOG FLOWMETER
Download PDF Clement Clarke, Inc.