510(k) · Cleared
ClearedSentinel, Model SP-001
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 Mar 30, 2009 as substantially equivalent to K052682 (Vision RT Limited, 2006) after a 203-day review. Its family tree reaches back 2 generations to 1999. 5 later devices descend from it.
- Decided
- Mar 30, 2009
- Review
- 203 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K981153 (1999). 3 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK981153 OsirisHuestis Medical · 1999
- 1 generation backK052682 AlignrtVision RT Limited · 2006 · Recalled
- This deviceK082582 Sentinel, Model SP-001C-Rad Positioning AB · 2009
- Descendant · cites it directly · 2 of its ownK113276 CatalystC-Rad Positioning AB · 2012 · Recalled
- Descendant · cites it directly · 1 of its ownK120668 SentinelC-Rad Positioning AB · 2012
- Descendant · 2 generations on · 0 of its ownK241937 Klarity SGRT System (ARSG-E1A, ARSG-E3A)Klarity Medical & Equipment (GZ) Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK200435 Catalyst+, Catalyst+ HDC-Rad Positioning AB · 2020 · Recalled
- Descendant · 2 generations on · 0 of its ownK200600 SentinelC-Rad Positioning AB · 2020
Most influential descendants
Showing 5 of 5 · See all- K113276CatalystC-Rad Positioning AB · 2012 · cites it directly2descendants
- K120668SentinelC-Rad Positioning AB · 2012 · cites it directly1descendant
- K241937Klarity SGRT System (ARSG-E1A, ARSG-E3A)Klarity Medical & Equipment (GZ) Co., Ltd. · 2025 · 2 generations on0descendants
- K200435Catalyst+, Catalyst+ HDC-Rad Positioning AB · 2020 · 2 generations on0descendants
- K200600SentinelC-Rad Positioning AB · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K981153 | Osiris | Huestis Medical | 1999 | — |
| −1 | K052682 | Alignrt | Vision RT Limited | 2006 | 1 |
| 0 (this device) | K082582 | Sentinel, Model SP-001 | C-Rad Positioning AB | 2009 | — |
| +1 | K113276 | Catalyst | C-Rad Positioning AB | 2012 | 1 |
| +1 | K120668 | Sentinel | C-Rad Positioning AB | 2012 | — |
| +2 | K241937 | Klarity SGRT System (ARSG-E1A, ARSG-E3A) | Klarity Medical & Equipment (GZ) Co., Ltd. | 2025 | — |
| +2 | K200435 | Catalyst+, Catalyst+ HD | C-Rad Positioning AB | 2020 | 2 |
| +2 | 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 |
|---|---|---|
| 2012 | 2 | 0 |
| 2020 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K052682 | AlignrtSummary page 1…Radiotherapy positioning system Classification name Medical charged-particle radiation therapy system Regulation: 21 CFR 892.5050 Predicate marketed devices AlignRT (K052682) - Vision RT Ltd. Sentinel 510(k) application Section 5 ';I (L-) qiimmnrv… | 2006 |
What descends from it? (5)
2 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?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 6.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K113276 (C-Rad Positioning AB, 2012) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K052682.
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?
The Sentinel system is intended for use in radiation therapy clinics to accurately position patients in a reproducible way, prior to treatment and to monitor the patient continuously during treatment. The system provides information about a patient's position and the adjustments required in order to position the patient as close as possible to a reference setup. During monitoring, the system reports deviations in the patient's position during treatment. The system shall only be used by hospital personnel, qualified to work in radiation therapy or diagnostics departments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082582 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082582: Sentinel, Model SP-001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082582
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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