Cleared Traditional

K912866 - PEAK EXPIRATORY FLOW METER

K912866 is the FDA 510(k) clearance for PEAK EXPIRATORY FLOW METER by Health Products, Inc.. It is a Class 2 Anesthesiology device (product code BZH) cleared through the Traditional 510(k) pathway after a 412-day FDA review.

K912866 · Health Products, Inc. · Anesthesiology device
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Aug 1992
Decision
412d
Days
Class 2
Risk

K912866 is an FDA 510(k) clearance for the PEAK EXPIRATORY FLOW METER. Classified as Meter, Peak Flow, Spirometry (product code BZH), Class II - Special Controls.

Submitted by Health Products, Inc. (Cedar Grove, US). The FDA issued a Cleared decision on August 13, 1992 after a review of 412 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.

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Submission Details

510(k) Number K912866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1991
Decision Date August 13, 1992
Days to Decision 412 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
272d slower than avg
Panel avg: 140d · This submission: 412d
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.