Cleared Traditional

K851828 - IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C (FDA 510(k) Clearance)

K851828 · Syncor Intl. Corp. · Radiology device
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Sep 1985
Decision
146d
Days
-
Risk

K851828 is an FDA 510(k) clearance for the IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C. Classified as Irradiator, Blood To Prevent Graft Versus Host Disease (product code MOT).

Submitted by Syncor Intl. Corp. (Sylmar, US). The FDA issued a Cleared decision on September 19, 1985 after a review of 146 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 Syncor Intl. Corp. devices

Submission Details

510(k) Number K851828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1985
Decision Date September 19, 1985
Days to Decision 146 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 107d · This submission: 146d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MOT Irradiator, Blood To Prevent Graft Versus Host Disease
Device Class -