510(k) · Cleared
ClearedPortable Dosimeter Dose Verification System, Model TD-RD-90
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Best Medical Canada, Ltd. · IYE Accelerator, Linear, Medical
Cleared on Aug 28, 2009 after a 30-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Aug 28, 2009
- Review
- 30 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK092285 Portable Dosimeter Dose Verification System, Model TD-RD-90Best Medical Canada, Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK250911 MOSkin Radiation Measurement SystemElectrogenics Labs, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK250083 PRO-DOSE SystemNu-Rise, SA · 2025
- Descendant · cites it directly · 0 of its ownK192196 Medical Radiation Dosimetry System microSTARiiLandauer · 2019 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K092285 | Portable Dosimeter Dose Verification System, Model TD-RD-90 | Best Medical Canada, Ltd. | 2009 | — |
| +1 | K250911 | MOSkin Radiation Measurement System | Electrogenics Labs, Ltd. | 2025 | — |
| +1 | K250083 | PRO-DOSE System | Nu-Rise, SA | 2025 | — |
| +1 | K192196 | Medical Radiation Dosimetry System microSTARii | Landauer | 2019 | 39 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IYE? 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 IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K250911 (Electrogenics Labs, Ltd., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
To provide dosimetry or to detect the dose delivered to a patient during therapeutic radiation procedures. The system is intended for the verification of the output of radiation producing devices.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K092285 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092285: Portable Dosimeter Dose Verification System, Model TD-RD-90.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092285
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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