Cleared Traditional

K851366 - COMPANION 2800 VOLUME VENTILATOR (FDA 510(k) Clearance)

K851366 · Puritan Bennett Corp. · Cardiovascular device
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Oct 1985
Decision
201d
Days
-
Risk

K851366 is an FDA 510(k) clearance for the COMPANION 2800 VOLUME VENTILATOR.

Submitted by Puritan Bennett Corp. (Overland Park, US). The FDA issued a Cleared decision on October 23, 1985 after a review of 201 days - an extended review cycle.

This device falls under the Cardiovascular 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Puritan Bennett Corp. devices

Submission Details

510(k) Number K851366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1985
Decision Date October 23, 1985
Days to Decision 201 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 125d · This submission: 201d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -