510(k) · Cleared
Recalled · Class II · 2011Varian High Energy Linear Accelerator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems · IYE Accelerator, Linear, Medical
Cleared on Jul 13, 2010 as substantially equivalent to K081188 (Varian Medical Systems, Inc., 2008) and 1 other predicate after a 104-day review. Its family tree reaches back 6 generations to 1991. 4 later devices descend from it. It has been recalled 11 times.
- Decided
- Jul 13, 2010
- Review
- 104 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 11
- Predicates
- 2
Its longest line of descent runs back 6 generations to K913119 (1991). 8 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK913119 Varian C-Series Clinacs (Clinac 2300C/D)Varian Assoc., Inc. · 1991 · Recalled
- 5 generations backK033343 Trilogy Radiotherapy Delivery SystemVarian Medical Systems, Inc. · 2003 · Recalled
- 4 generations backK061140 Trilogy Radiotherapy Delivery SystemVarian Medical Systems · 2006
- 3 generations backK070094 Trilogy Radiotherapy Delivery System and Trilogy TX Delivery SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 2 generations backK072916 Trilogy System with RapidarcVarian Medical Systems, Inc. · 2007 · Recalled
- 1 generation backK081188 Trilogy with External System Gating InterfaceVarian Medical Systems, Inc. · 2008 · Recalled
- This deviceK100890 Varian High Energy Linear AcceleratorVarian Medical Systems · 2010
- Descendant · cites it directly · 3 of its ownK112839 Varian High Energy Linear AcceleratorVarian Medical Systems · 2011 · Recalled
- Descendant · 2 generations on · 2 of its ownK131807 High Energy Linear AcceleratorVarian Medical Systems, Inc. · 2013 · Recalled
- Descendant · 3 generations on · 1 of its ownK162476 Varian High Energy Linear AcceleratorVarian Medical Systems, Inc. · 2016
- Descendant · 4 generations on · 0 of its ownK181404 Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf…Varian Medical Systems, Inc. · 2018 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K112839Varian High Energy Linear AcceleratorVarian Medical Systems · 2011 · cites it directly3descendants
- K131807High Energy Linear AcceleratorVarian Medical Systems, Inc. · 2013 · 2 generations on2descendants
- K162476Varian High Energy Linear AcceleratorVarian Medical Systems, Inc. · 2016 · 3 generations on1descendant
- K181404Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf CollimatorVarian Medical Systems, Inc. · 2018 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K913119 | Varian C-Series Clinacs (Clinac 2300C/D) | Varian Assoc., Inc. | 1991 | 6 |
| −5 | K033343 | Trilogy Radiotherapy Delivery System | Varian Medical Systems, Inc. | 2003 | 3 |
| −4 | K061140 | Trilogy Radiotherapy Delivery System | Varian Medical Systems | 2006 | — |
| −3 | K070094 | Trilogy Radiotherapy Delivery System and Trilogy TX Delivery System | Varian Medical Systems, Inc. | 2007 | 5 |
| −2 | K072916 | Trilogy System with Rapidarc | Varian Medical Systems, Inc. | 2007 | 2 |
| −1 | K081188 | Trilogy with External System Gating Interface | Varian Medical Systems, Inc. | 2008 | 1 |
| 0 (this device) | K100890 | Varian High Energy Linear Accelerator | Varian Medical Systems | 2010 | — |
| +1 | K112839 | Varian High Energy Linear Accelerator | Varian Medical Systems | 2011 | 1 |
| +2 | K131807 | High Energy Linear Accelerator | Varian Medical Systems, Inc. | 2013 | 2 |
| +3 | K162476 | Varian High Energy Linear Accelerator | Varian Medical Systems, Inc. | 2016 | — |
| +4 | K181404 | Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator | Varian Medical Systems, Inc. | 2018 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K081188 | Trilogy with External System Gating InterfaceSummary page 1…Class II Product Code: 90 lYE 3. Predicate Device: Varian Trilogy Radiotherapy System: K081 188, K072916 4. Description of the Device: The Varian High Energy Linear Accelerator models provide various selec… | 2008 |
| * | K072916 | Trilogy System with RapidarcSummary page 1…Class II Product Code: 90 lYE 3. Predicate Device: Varian Trilogy Radiotherapy System: K081 188, K072916 4. Description of the Device: The Varian High Energy Linear Accelerator models provide various selections amo… | 2007 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112839 | Varian High Energy Linear Accelerator | 2011 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 9, 2011 | Not classified | Z-0181-2012 | Device Design | Varian has received reports in which a user has remotely rotated the gantry into contact with the couch or with the patient, in both the manual mode and the automate mode. |
| May 31, 2011 | Class II | Z-1325-2013 | Process design | Under certain conditions, photon beams in High Energy Clinacs may experience a gradual change in beam symmetry, potentially reaching an asymmetry of up to about 7% before interlock occurs. At maximum asymmetry, this may result in no more… |
| May 26, 2011 | Not classified | Z-2978-2011 | Device Design | On Varian Linear Accelerators where the customer may calibrate the collimator angle position readout in reverse, switching the 90 degree and 270 degree positions. |
| May 24, 2011 | Not classified | Z-2893-2011 | Device Design | The throat cover on the High Energy Clinac may detach if not properly installed and possibly strike a patient. |
| May 18, 2011 | Not classified | Z-2764-2011 | Other | The Coolant System input water supply manifold may leak in some Clinac Linear Accelerators, posing a risk of electrical shock to any person working within the protective housing. |
| May 13, 2011 | Not classified | Z-2778-2011 | Nonconforming Material/Component | Some drive stand bolts may fail to meet mechanical specifications. |
| Mar 31, 2011 | Not classified | Z-2224-2011 | Process design | The coolant may leak. The resulting coolant leak presents a risk of electrical shock to any person working within the protective housing. |
| Mar 28, 2011 | Not classified | Z-2195-2011 | Process control | Varian has identified an anomaly whereby, following prolonged use, the screw fastener holding the wedge body to the tray may fail. |
| Mar 17, 2011 | Not classified | Z-3204-2011 | Component design/selection | An improperly installed collimator cover may detach and fall from the machine, potentially striking the patient or nearby personnel. |
| Feb 24, 2011 | Not classified | Z-2046-2011 | Labeling mix-ups | The wedge angle labeling on the wedge tray may not correctly match the wedge body. However, the wedge body is labeled with the correct wedge angle. |
| Dec 10, 2010 | Not classified | Z-1045-2011 | Process control | An anomaly was identified whereby the bolts used to fasten the counterweight to the gantry may not, in some cases, be fully tightened to the required torque specification. |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 6 of the 8 ancestors have a recall of any class.
- Of its descendants, K112839 (Varian Medical Systems, 2011) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K081188.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100890 · printed Nov 5, 2026
Cite this page
510(k) Report. “K100890: Varian High Energy Linear Accelerator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K100890
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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