Cleared Traditional

K864394 - EMERSON 3MV VOLUME VENTILATOR (FDA 510(k) Clearance)

K864394 · J. H. Emerson Co. · Anesthesiology device
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Dec 1986
Decision
29d
Days
-
Risk

K864394 is an FDA 510(k) clearance for the EMERSON 3MV VOLUME VENTILATOR.

Submitted by J. H. Emerson Co. (Cambridge, US). The FDA issued a Cleared decision on December 5, 1986 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel. 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 J. H. Emerson Co. devices

Submission Details

510(k) Number K864394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1986
Decision Date December 05, 1986
Days to Decision 29 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 139d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -