Cleared Traditional

K760736 - BARIMEX, BARIUM SULFATE COMPOUND (FDA 510(k) Clearance)

K760736 · C.R. Bard, Inc. · Radiology device
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Nov 1976
Decision
42d
Days
-
Risk

K760736 is an FDA 510(k) clearance for the BARIMEX, BARIUM SULFATE COMPOUND. Classified as Medium, Contrast, Radiologic (product code KTA).

Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 9, 1976 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Radiology 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K760736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1976
Decision Date November 09, 1976
Days to Decision 42 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 107d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KTA Medium, Contrast, Radiologic
Device Class -