Cleared Traditional

K854626 - COMPUMED PULMONARY FUNCTION ANALYZER MODEL 307B (FDA 510(k) Clearance)

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

K854626 · Compumed, Inc. · Anesthesiology device
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Feb 1986
Decision
102d
Days
Class 2
Risk

K854626 is an FDA 510(k) clearance for the COMPUMED PULMONARY FUNCTION ANALYZER MODEL 307B. Classified as Calculator, Pulmonary Function Data (product code BZC), Class II - Special Controls.

Submitted by Compumed, Inc. (Culver City, US). The FDA issued a Cleared decision on February 28, 1986 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1880 - 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 Compumed, Inc. devices

Submission Details

510(k) Number K854626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1985
Decision Date February 28, 1986
Days to Decision 102 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 139d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZC Calculator, Pulmonary Function Data
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1880
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.