Cleared Traditional

K915059 - PEAK FLOW MONITOR

K915059 is the FDA 510(k) clearance for PEAK FLOW MONITOR by Spirometrics, Inc.. It is a Class 2 Anesthesiology device (product code BZH) cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K915059 · Spirometrics, Inc. · Anesthesiology device
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Jul 1992
Decision
262d
Days
Class 2
Risk

K915059 is an FDA 510(k) clearance for the PEAK FLOW MONITOR. Classified as Meter, Peak Flow, Spirometry (product code BZH), Class II - Special Controls.

Submitted by Spirometrics, Inc. (Auburn, US). The FDA issued a Cleared decision on July 27, 1992 after a review of 262 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.

View all Spirometrics, Inc. devices

Submission Details

510(k) Number K915059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1991
Decision Date July 27, 1992
Days to Decision 262 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
122d slower than avg
Panel avg: 140d · This submission: 262d
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.