Cleared Traditional

K851366 - COMPANION 2800 VOLUME VENTILATOR

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

FDA 510(k) Submission Details - K851366

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 125d · This submission: 201d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -