510(k) · Cleared

Cleared

Raycell

K032684510(k) SpecialCleared Sep 26, 200328-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Mds Nordion · MOT Irradiator, Blood To Prevent Graft Versus Host Disease

Cleared on Sep 26, 2003 as substantially equivalent to K974210 (Rad-Source, Inc., 1998) after a 28-day review. Its family tree reaches back 2 generations to 1987.

Decided: Sep 26, 2003
Review: 28 days
Class: Class U
Product code: MOT
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K865027 (1987). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK865027 Irradiator for Biological Materials, Ibl-137CCis-Us, Inc. · 1987
1 generation backK974210 Shielded Cabinet X-Ray Radiation Source Device Model RS 3000Rad-Source, Inc. · 1998 · Recalled
This deviceK032684 RaycellMds Nordion · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K865027	Irradiator for Biological Materials, Ibl-137C	Cis-Us, Inc.	1987	—
−1	K974210	Shielded Cabinet X-Ray Radiation Source Device Model RS 3000	Rad-Source, Inc.	1998	1
0 (this device)	K032684	Raycell	Mds Nordion	2003	—

FIG. 1 — Lineage of K032684, 1987–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MOT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MOT device

#1 K201177 RadGil2score 0.8 · 4 generations · no Class I recall

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K974210	Shielded Cabinet X-Ray Radiation Source Device Model RS 3000 Summary page 2 …Research, FDA to all registered blood establishments). 2.9 Summary of Technological Characteristics: The Raycell is substantially equivalent to the RS 3000 (K974210). Both are indicated for the irradiation of blood and blood products to reduce the risk of transfusion-associated gra…	Rad-Source, Inc.	1998	1

Also cleared against K974210: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 11.1 years on median.
1 of the 2 ancestors has a recall of any class.
1 other device also cites its predicate K974210.

How does its category compare?

All MOT devices

MOT Irradiator, Blood To Prevent Graft Versus Host Disease: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MOT

1in 2020

2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MOT

Too few MOT 510(k)s in any year since 2007 to give a median.

Recalls per year · MOT

No recall names MOT since 2007.

Adverse event reports per year · MOT

1in 2014

2007high 2 (2010) · low 0 (2007)2025

MAUDE reports naming product code MOT, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	1	—	1
2010	0	—	2
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	1
2015	0	—	0
2016	1	—	0
2017	1	—	0
2018	0	—	0
2019	1	—	0
2020	1	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The RaycellTM Cabinet X-ray System is intended for the irradiation of blood and blood products packaged in transfusion bags when irradiation to reduce the risk of Graft versus Host Disease is indicated, and is used in accordance with “Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products” (22 July 1993 memorandum from Acting Director, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA to all registered blood establishments).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032684 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032684: Raycell.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032684

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026