Cleared Traditional

K861929 - PULMONARY FUNCTION TEST LABORATORY, SYSTEM 1070 (FDA 510(k) Clearance)

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

K861929 · Medical Graphics Corp. · Anesthesiology device
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Sep 1986
Decision
129d
Days
Class 2
Risk

K861929 is an FDA 510(k) clearance for the PULMONARY FUNCTION TEST LABORATORY, SYSTEM 1070. Classified as Calculator, Pulmonary Function Interpretor (diagnostic) (product code BZM), Class II - Special Controls.

Submitted by Medical Graphics Corp. (St. Paul, US). The FDA issued a Cleared decision on September 26, 1986 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1900 - 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.

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Submission Details

510(k) Number K861929 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received May 20, 1986
Decision Date September 26, 1986
Days to Decision 129 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 139d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZM Calculator, Pulmonary Function Interpretor (diagnostic)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1900
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.