Cleared Traditional

K851851 - STERILE ENDOTRACHEAL BRUSHES (FDA 510(k) Clearance)

K851851 · Biological & Environmental Control Laboratories · Cardiovascular device
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Jun 1985
Decision
40d
Days
-
Risk

K851851 is an FDA 510(k) clearance for the STERILE ENDOTRACHEAL BRUSHES.

Submitted by Biological & Environmental Control Laboratories (Toledo, US). The FDA issued a Cleared decision on June 5, 1985 after a review of 40 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K851851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1985
Decision Date June 05, 1985
Days to Decision 40 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 125d · This submission: 40d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -