Cleared Traditional

K800459 - BARIUM SULFATE, USP IN SUSPENSION (FDA 510(k) Clearance)

K800459 · Central Pharmaceuticals, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1980
Decision
91d
Days
-
Risk

K800459 is an FDA 510(k) clearance for the BARIUM SULFATE, USP IN SUSPENSION. Classified as Medium, Contrast, Radiologic (product code KTA).

Submitted by Central Pharmaceuticals, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 30, 1980 after a review of 91 days - within the typical 510(k) review window.

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

View all Central Pharmaceuticals, Inc. devices

Submission Details

510(k) Number K800459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 1980
Decision Date May 30, 1980
Days to Decision 91 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 107d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KTA Medium, Contrast, Radiologic
Device Class -