510(k) · Cleared
ClearedRF-Ivd Wireless Dosimeter-Model 1133
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sun Nuclear Corp. · IYE Accelerator, Linear, Medical
Cleared on Jul 26, 2001 after an 85-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.
- Decided
- Jul 26, 2001
- Review
- 85 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 2 citing it directly.
- This deviceK011332 RF-Ivd Wireless Dosimeter-Model 1133Sun Nuclear Corp. · 2001
- Descendant · cites it directly · 11 of its ownK021463 Model 1133 Ivd PC VersionSun Nuclear Corp. · 2002
- Descendant · cites it directly · 10 of its ownK040687 Onedose Patient Dosimetry SystemSicel Technologies, Inc. · 2004
- Descendant · 2 generations on · 8 of its ownK052118 Dose Verification SystemSicel Technologies, Inc. · 2006
- Descendant · 3 generations on · 7 of its ownK061051 Dose Verification System Patient Dosimetry System, Models DVS-I-11…Sicel Technologies, Inc. · 2006
- Descendant · 3 generations on · 6 of its ownK071399 Dose Verification System Patient Dosimetry System, Model DVS-I-11…Sicel Technologies, Inc. · 2007
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K021463Model 1133 Ivd PC VersionSun Nuclear Corp. · 2002 · cites it directly11descendants
- K040687Onedose Patient Dosimetry SystemSicel Technologies, Inc. · 2004 · cites it directly10descendants
- K052118Dose Verification SystemSicel Technologies, Inc. · 2006 · 2 generations on8descendants
- K061051Dose Verification System Patient Dosimetry System, Models DVS-I-11, DVS Insertion Tool…Sicel Technologies, Inc. · 2006 · 3 generations on7descendants
- K071399Dose Verification System Patient Dosimetry System, Model DVS-I-11: DVS Insertion Tool…Sicel Technologies, Inc. · 2007 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011332 | RF-Ivd Wireless Dosimeter-Model 1133 | Sun Nuclear Corp. | 2001 | — |
| +1 | K021463 | Model 1133 Ivd PC Version | Sun Nuclear Corp. | 2002 | — |
| +1 | K040687 | Onedose Patient Dosimetry System | Sicel Technologies, Inc. | 2004 | — |
| +2 | K052118 | Dose Verification System | Sicel Technologies, Inc. | 2006 | — |
| +3 | K061051 | Dose Verification System Patient Dosimetry System, Models DVS-I-11, DVS… | Sicel Technologies, Inc. | 2006 | — |
| +3 | K071399 | Dose Verification System Patient Dosimetry System, Model DVS-I-11: DVS… | Sicel Technologies, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (12)
See all 122 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, K021463 (Sun Nuclear Corp., 2002) has gone furthest, with 11 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.
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 | — |
https://510kreport.com/device/K011332 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011332: RF-Ivd Wireless Dosimeter-Model 1133.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011332
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026