Cleared Traditional

K864430 - MA-2 AND MA2+2 VOLUME VENTILATORS (FDA 510(k) Clearance)

K864430 · Puritan Bennett Corp. · Anesthesiology device
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Jan 1987
Decision
64d
Days
-
Risk

K864430 is an FDA 510(k) clearance for the MA-2 AND MA2+2 VOLUME VENTILATORS.

Submitted by Puritan Bennett Corp. (Overland Park, US). The FDA issued a Cleared decision on January 15, 1987 after a review of 64 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 Puritan Bennett Corp. devices

Submission Details

510(k) Number K864430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1986
Decision Date January 15, 1987
Days to Decision 64 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 139d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -