510(k) · Cleared
ClearedXknife Radiosurgery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rsa, Inc. · IYE Accelerator, Linear, Medical
Cleared on Nov 4, 1991 after a 140-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- Nov 4, 1991
- Review
- 140 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 5 citing it directly.
- This deviceK912630 Xknife Radiosurgery SystemRsa, Inc. · 1991
- Descendant · cites it directly · 0 of its ownK100096 Linac Collimator Assembly Housing (Lcah) Model LcahartIntegra Radionics, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK072454 Integra Radionics Interfix Patient AdaptersIntegra Radionics, Inc. · 2007 · Recalled
- Descendant · cites it directly · 0 of its ownK043409 AccuchangerDirex Systems Corp. · 2005
- Descendant · cites it directly · 0 of its ownK963860 The Nomos Talon Positioning and Immobilization SystemNomos Corp. · 1996
- Descendant · cites it directly · 0 of its ownK961484 Cass System (Modification)Medical Instrumentation & Diagnostics Corp.(Midco) · 1996
Most influential descendants
Showing 5 of 5 · See all- K100096Linac Collimator Assembly Housing (Lcah) Model LcahartIntegra Radionics, Inc. · 2010 · cites it directly0descendants
- K072454Integra Radionics Interfix Patient AdaptersIntegra Radionics, Inc. · 2007 · cites it directly0descendants
- K043409AccuchangerDirex Systems Corp. · 2005 · cites it directly0descendants
- K963860The Nomos Talon Positioning and Immobilization SystemNomos Corp. · 1996 · cites it directly0descendants
- K961484Cass System (Modification)Medical Instrumentation & Diagnostics Corp.(Midco) · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K912630 | Xknife Radiosurgery System | Rsa, Inc. | 1991 | — |
| +1 | K100096 | Linac Collimator Assembly Housing (Lcah) Model Lcahart | Integra Radionics, Inc. | 2010 | — |
| +1 | K072454 | Integra Radionics Interfix Patient Adapters | Integra Radionics, Inc. | 2007 | 1 |
| +1 | K043409 | Accuchanger | Direx Systems Corp. | 2005 | — |
| +1 | K963860 | The Nomos Talon Positioning and Immobilization System | Nomos Corp. | 1996 | — |
| +1 | K961484 | Cass System (Modification) | Medical Instrumentation & Diagnostics Corp.(Midco) | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
5 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, K100096 (Integra Radionics, Inc., 2010) has gone furthest, with 0 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/K912630 · printed Nov 6, 2026
Cite this page
510(k) Report. “K912630: Xknife Radiosurgery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K912630
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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