FDA product code MOT: Irradiator, Blood To Prevent Graft Versus Host Disease
MOT is the FDA product code for irradiator, blood to prevent graft versus host disease. It is a Unclassified device, reviewed by the Radiology panel. FDA has cleared 16 510(k) submissions under MOT, from 11 different applicants. The average 510(k) review took 246 days (median 104). FDA has posted 2 recalls for MOT devices.
Classification
| Field | Value |
|---|---|
| Device name | Irradiator, Blood To Prevent Graft Versus Host Disease |
| Device class | Unclassified |
| Review panel | RA — Radiology |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
510(k) clearances per year for MOT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 108 |
| 2019 | 1 | 184 |
| 2020 | 1 | 108 |
Compare with all 510(k) review times · Search every MOT clearance
Top MOT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mds Nordion | 3 | 2005-05-26 |
| Best Theratronics Limited | 2 | 2019-01-02 |
| Nordion International, Inc. | 2 | 1996-11-08 |
| J. L. Shepherd and Assoc. | 2 | 1995-07-12 |
| R3 X-Ray L.L.C | 1 | 2020-08-17 |
6 more applicants have MOT clearances. See the full list in Caduvo.
Most recent MOT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K201177 | R3 X-Ray L.L.C | RadGil2 | 2020-08-17 | 108 |
| K181737 | Best Theratronics Limited | Raycell MK1 | 2019-01-02 | 184 |
| K172087 | Hitachi , Ltd. | SANGRAY | 2017-10-27 | 108 |
| K161324 | Best Theratronics Limited | Raycell Mk2 | 2016-08-12 | 93 |
| K082921 | Rad Source Technologies, Inc. | RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400 | 2009-02-17 | 139 |
Recalls for MOT devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-05-06.
Frequently asked questions
What is FDA product code MOT?
MOT is the FDA product code for irradiator, blood to prevent graft versus host disease. It is a Unclassified device, reviewed by the Radiology panel.
What device class is MOT?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code MOT?
Across 16 cleared submissions the average was 246 days from receipt to decision (median 104).
Which companies have the most MOT clearances?
Mds Nordion (3); Best Theratronics Limited (2); Nordion International, Inc. (2); J. L. Shepherd and Assoc. (2); R3 X-Ray L.L.C (1).
Have MOT devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2016-05-06.
Next steps
- Run an FDA pathway report with predicate devices for product code MOT
- Run a recall and safety report across every MOT manufacturer
- Watch product code MOT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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