510(k) · Cleared
Recalled · Class II · 2025Catalyst+, Catalyst+ HD
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 May 7, 2020 as substantially equivalent to K113276 (C-Rad Positioning AB, 2012) after a 73-day review. Its family tree reaches back 5 generations to 1987. It has been recalled 2 times.
- Decided
- May 7, 2020
- Review
- 73 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 5 generations to K864886 (1987). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK864886 Respigraph-Respisomnograph-RespicentralNims/Respitrace Corp. · 1987
- 4 generations backK983629 RPM Respiratory Gating SystemVarian Medical Systems, Inc. · 1999
- 3 generations backK063270 RPM Respiratory Gating SystemVarian Medical Systems, Inc. · 2006 · Recalled
- 2 generations backK072171 Gatect-RTVision RT Limited · 2007
- 1 generation backK113276 CatalystC-Rad Positioning AB · 2012 · Recalled
- This deviceK200435 Catalyst+, Catalyst+ HDC-Rad Positioning AB · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K864886 | Respigraph-Respisomnograph-Respicentral | Nims/Respitrace Corp. | 1987 | — |
| −4 | K983629 | RPM Respiratory Gating System | Varian Medical Systems, Inc. | 1999 | — |
| −3 | K063270 | RPM Respiratory Gating System | Varian Medical Systems, Inc. | 2006 | 1 |
| −2 | K072171 | Gatect-RT | Vision RT Limited | 2007 | — |
| −1 | K113276 | Catalyst | C-Rad Positioning AB | 2012 | 1 |
| 0 (this device) | K200435 | Catalyst+, Catalyst+ HD | C-Rad Positioning AB | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2006 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K113276 | CatalystSummary page 4…iotherapy positioning system Classification name: Medical charged-particle radiation therapy system Regulation: 21 CFR 892.5050 Predicate marketed device(s): Catalyst (K113276) Device description: The Catalyst+ product consists of projector unit hardware and Windows based software. The product is intend… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 9, 2025 | Class II | Z-1092-2026 | Under Investigation by firm | Due to issues with the system's stereotactic radiosurgery (SRS) treatment cannot be guaranteed for all couch angles and system setups. n certain cases, the system may indicate the patient as correctly positioned at the isocenter, even… |
| Apr 22, 2025 | Class II | Z-1858-2025 | Software design | Software issue with scanning equipment that can results in the filed rotation not being applied correctly. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 33 years and passes through 4 companies; a new generation was cleared every 7.5 years on median.
- 3 of the 9 ancestors have a recall of any class.
- 1 other device also cites its predicate K113276.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 and accessories are intended for use in radiation therapy clinics with treatment equipment, to
provide:
• Interactive guidance for setup and positioning of patients for radiation therapy
• Intra-fraction motion detection during radiation therapy
• Respiratory gating during radiation therapy
The device is not intended for use in MR-linac systems.
The system shall only be used by hospital personnel, qualified to work in radiation therapy departments. Training on the
use of the system will be given to users at the time of installation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200435 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200435: Catalyst+, Catalyst+ HD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200435
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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