Cleared Traditional

K915766 - MODEL 109 SERIES BLOOD PRODUCTS IRRADIATORS (FDA 510(k) Clearance)

K915766 · J. L. Shepherd and Assoc. · Radiology device
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Optimized for regulatory review, auditing and printing
Jul 1995
Decision
1296d
Days
-
Risk

K915766 is an FDA 510(k) clearance for the MODEL 109 SERIES BLOOD PRODUCTS IRRADIATORS. Classified as Irradiator, Blood To Prevent Graft Versus Host Disease (product code MOT).

Submitted by J. L. Shepherd and Assoc. (San Fernando, US). The FDA issued a Cleared decision on July 12, 1995 after a review of 1296 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all J. L. Shepherd and Assoc. devices

Submission Details

510(k) Number K915766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1991
Decision Date July 12, 1995
Days to Decision 1296 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1189d slower than avg
Panel avg: 107d · This submission: 1296d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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