Cleared Traditional

BRONCHIAL CYTOLOGY BRUSH (K853667) - FDA 510(k) Clearance

K853667 · E-Z-Em, Inc. · Cardiovascular device
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Dec 1985
Decision
106d
Days
-
Risk

K853667 is an FDA 510(k) clearance for the BRONCHIAL CYTOLOGY BRUSH.

Submitted by E-Z-Em, Inc. (Westbury, US). The FDA issued a Cleared decision on December 18, 1985 after a review of 106 days - within the typical 510(k) review window.

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 E-Z-Em, Inc. devices

Submission Details

510(k) Number K853667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1985
Decision Date December 18, 1985
Days to Decision 106 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 125d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -