510(k) · Cleared
ClearedSentinel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C-Rad Positioning AB · IYE Accelerator, Linear, Medical
Cleared on Jul 30, 2012 as substantially equivalent to K082582 (C-Rad Positioning AB, 2009) after a 147-day review. Its family tree reaches back 3 generations to 1999. 1 later device descends from it.
- Decided
- Jul 30, 2012
- Review
- 147 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K981153 (1999). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK981153 OsirisHuestis Medical · 1999
- 2 generations backK052682 AlignrtVision RT Limited · 2006 · Recalled
- 1 generation backK082582 Sentinel, Model SP-001C-Rad Positioning AB · 2009
- This deviceK120668 SentinelC-Rad Positioning AB · 2012
- Descendant · cites it directly · 0 of its ownK200600 SentinelC-Rad Positioning AB · 2020
Most influential descendants
Showing 1 of 1 · See all- K200600SentinelC-Rad Positioning AB · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K981153 | Osiris | Huestis Medical | 1999 | — |
| −2 | K052682 | Alignrt | Vision RT Limited | 2006 | 1 |
| −1 | K082582 | Sentinel, Model SP-001 | C-Rad Positioning AB | 2009 | — |
| 0 (this device) | K120668 | Sentinel | C-Rad Positioning AB | 2012 | — |
| +1 | K200600 | Sentinel | C-Rad Positioning AB | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
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 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? (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 | Decided |
|---|---|---|---|
| * | K082582 | Sentinel, Model SP-001Summary page 1…otherapy positioning system Classification name Medical charged-particle radiation therapy system Regulation: 21 CFR 892.5050 Predicate marketed devices Sentinel (1K082582) - C-RAD Positioning AB Sentinel Traditional 510(k) application Section 2 Traditional 510(k) Summary… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200600 | Sentinel | 2020 | 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?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K200600 (C-Rad Positioning AB, 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K082582.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
The system is intended for use in radiation therapy clinics together with diagnostic or treatment equipment and provides: * accurate and reproducible patient positioning. * patient motion supervision with an audible and/or visual alarm whenever the patient motion during treatment is outside of the specified tolerance values, while still allowing for normal breathing motion without triggering the alarm. * a respiratory signal to be supplied to diagnostic…
Read the full statement (123 words)
The system is intended for use in radiation therapy clinics together with
diagnostic or treatment equipment and provides:
* accurate and reproducible patient positioning.
* patient motion supervision with an audible and/or visual alarm whenever
the patient motion during treatment is outside of the specified tolerance
values, while still allowing for normal breathing motion without triggering the
alarm.
* a respiratory signal to be supplied to diagnostic imaging equipment
(primarily CTs) for prospectively and retrospectively (alka 4DCT) gated
imaging and reconstruction.
The system cannot directly determine the location of the intended treatment
target, since only the patient external surface is detected. The actual target
position must therefore, whenever deemed necessary by qualified personnel, be
verified using other systems such as CBCT or EPID.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120668 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120668: Sentinel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120668
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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