Cleared Traditional

K865027 - IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C

K865027 · Cis-Us, Inc. · Radiology device
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Feb 1987
Decision
65d
Days
-
Risk

K865027 is an FDA 510(k) clearance for the IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C. Classified as Irradiator, Blood To Prevent Graft Versus Host Disease (product code MOT).

Submitted by Cis-Us, Inc. (Lake Success, US). The FDA issued a Cleared decision on February 26, 1987 after a review of 65 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 Cis-Us, Inc. devices

FDA 510(k) Submission Details - K865027

510(k) Number K865027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1986
Decision Date February 26, 1987
Days to Decision 65 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 107d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

MOT Device Classification - Class 0,

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

Regulatory Peers - MOT Irradiator, Blood To Prevent Graft Versus Host Disease

All 10
Devices cleared under the same product code (MOT) and FDA review panel - the closest regulatory comparables to K865027.
GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN
K050963 · Mds Nordion · May 2005
SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000
K974210 · Rad-Source, Inc. · Mar 1998
GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0
K963497 · Nordion International, Inc. · Nov 1996
IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C
K851828 · Syncor Intl. Corp. · Sep 1985