Cleared Traditional

K861486 - SPIROMETRY MODULE (FDA 510(k) Clearance)

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

K861486 · Medical Graphics Corp. · Anesthesiology device
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May 1986
Decision
27d
Days
Class 2
Risk

K861486 is an FDA 510(k) clearance for the SPIROMETRY MODULE. Classified as Calculator, Predicted Values, Pulmonary Function (product code BTY), Class II - Special Controls.

Submitted by Medical Graphics Corp. (St. Paul, US). The FDA issued a Cleared decision on May 19, 1986 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1890 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medical Graphics Corp. devices

Submission Details

510(k) Number K861486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1986
Decision Date May 19, 1986
Days to Decision 27 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 139d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTY Calculator, Predicted Values, Pulmonary Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1890
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 - BTY Calculator, Predicted Values, Pulmonary Function

All 62
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