510(k) · Cleared

Cleared

Raycell Mk2

K161324510(k) SpecialCleared Aug 12, 201693-day reviewClass U

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

Best Theratronics Limited · MOT Irradiator, Blood To Prevent Graft Versus Host Disease

Cleared on Aug 12, 2016 as substantially equivalent to K051065 (Mds Nordion, 2005) after a 93-day review. Its family tree reaches back 1 generation to 2005. 1 later device descends from it.

Decided: Aug 12, 2016
Review: 93 days
Class: Class U
Product code: MOT
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K051065 (2005). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK051065 Raycell X-Ray Blood IrradiatorMds Nordion · 2005
This deviceK161324 Raycell Mk2Best Theratronics Limited · 2016
Descendant · cites it directly · 0 of its ownK181737 Raycell MK1Best Theratronics Limited · 2019

Most influential descendants

Showing 1 of 1 · See all

K181737Raycell MK1Best Theratronics Limited · 2019 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K051065	Raycell X-Ray Blood Irradiator	Mds Nordion	2005	—
0 (this device)	K161324	Raycell Mk2	Best Theratronics Limited	2016	—
+1	K181737	Raycell MK1	Best Theratronics Limited	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0

FIG. 1 — Lineage of K161324, 2005–2019Source: 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
*	K051065	Raycell X-Ray Blood Irradiator Summary page 4 …X-Ray Blood Irradiator Classification Name Blood irradiators have not been classified Legally Marketed Predicate Device Raycell (K051065) Device Classification None Product Code 90 MOT Description of Device…	Mds Nordion	2005	—

Also cleared against K051065: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K181737	Raycell MK1	Best Theratronics Limited	2019	0

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?

Its one ancestor has no recall.
Of its descendants, K181737 (Best Theratronics Limited, 2019) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K051065.

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. 2016, this device’s year, is highlighted.

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 Raycell X-ray Blood Irradiator is intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease according to applicable FDA, AABB, Health Canada, and European guidelines.

The Raycell X-ray Blood Irradiator is also intended for use in the irradiation of intra-operatively salvaged blood for cancer patients undergoing surgery to assist in the prevention of metastasis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K161324 · printed Nov 6, 2026

Cite this page

510(k) Report. “K161324: Raycell Mk2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161324

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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