510(k) · Cleared
Recalled · Class II · 2020Catalyst
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 Feb 27, 2012 as substantially equivalent to K082582 (C-Rad Positioning AB, 2009) and 1 other predicate after a 112-day review. Its family tree reaches back 4 generations to 1987. 2 later devices descend from it. It has been recalled once.
- Decided
- Feb 27, 2012
- Review
- 112 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K864886 (1987). 8 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK864886 Respigraph-Respisomnograph-RespicentralNims/Respitrace Corp. · 1987
- 3 generations backK983629 RPM Respiratory Gating SystemVarian Medical Systems, Inc. · 1999
- 2 generations backK063270 RPM Respiratory Gating SystemVarian Medical Systems, Inc. · 2006 · Recalled
- 1 generation backK072171 Gatect-RTVision RT Limited · 2007
- This deviceK113276 CatalystC-Rad Positioning AB · 2012
- Descendant · cites it directly · 0 of its ownK241937 Klarity SGRT System (ARSG-E1A, ARSG-E3A)Klarity Medical & Equipment (GZ) Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK200435 Catalyst+, Catalyst+ HDC-Rad Positioning AB · 2020 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K864886 | Respigraph-Respisomnograph-Respicentral | Nims/Respitrace Corp. | 1987 | — |
| −3 | K983629 | RPM Respiratory Gating System | Varian Medical Systems, Inc. | 1999 | — |
| −2 | K063270 | RPM Respiratory Gating System | Varian Medical Systems, Inc. | 2006 | 1 |
| −1 | K072171 | Gatect-RT | Vision RT Limited | 2007 | — |
| 0 (this device) | K113276 | Catalyst | C-Rad Positioning AB | 2012 | — |
| +1 | K241937 | Klarity SGRT System (ARSG-E1A, ARSG-E3A) | Klarity Medical & Equipment (GZ) Co., Ltd. | 2025 | — |
| +1 | K200435 | Catalyst+, Catalyst+ HD | C-Rad Positioning AB | 2020 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 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? (2)
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…therapy Positioning system Classification name Medical charged-particle radiation therapy system Regulation: 21 CER 892.5050 Predicate marketed devices Sentinel (K(082582) - C-RAD Positioning AB GateCT-RT (K(072171) - Vision RT Ltd. Catalyst 510(k) application Secti… | 2009 |
| * | K072171 | Gatect-RTSummary page 1…name Medical charged-particle radiation therapy system Regulation: 21 CER 892.5050 Predicate marketed devices Sentinel (K(082582) - C-RAD Positioning AB GateCT-RT (K(072171) - Vision RT Ltd. Catalyst 510(k) application Section 5 5 10(k) Summary… | 2007 |
What descends from it? (2)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 6, 2020 | Class II | Z-2075-2021 | Component change control | PC Application Software c4D not changing Site upon synchronization during the Setup workflow step |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 7.5 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K241937 (Klarity Medical & Equipment (GZ) Co., Ltd., 2025) 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 Catalyst system is intended for use in radiation therapy clinics to accurately set-up and 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 inorder to position the patient as close as possible to a reference setup. During monitoring, the system reports deviations in the patient's position during…
Read the full statement (116 words)
The Catalyst system is intended for use in radiation therapy clinics to accurately
set-up and 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 inorder 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 and.
disables the treatment beam in case of large detected movements. The system
can also track the patient's respiratory motion for supporting synchronized image
acquisition or treatment delivery.
The system shall only be used by hospital personnel, qualified to work in radiation
therapy or diagnostic imaging departments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113276 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113276: Catalyst.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113276
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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