510(k) · Cleared
Recalled · Class II · 2019Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems, Inc. · IYE Accelerator, Linear, Medical
Cleared on Jun 28, 2018 as substantially equivalent to K162476 (Varian Medical Systems, Inc., 2016) and 2 other predicates after a 30-day review. Its family tree reaches back 10 generations to 1991. It has been recalled once.
- Decided
- Jun 28, 2018
- Review
- 30 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 10 generations to K913119 (1991). 22 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK913119 Varian C-Series Clinacs (Clinac 2300C/D)Varian Assoc., Inc. · 1991 · Recalled
- 6 generations between
- 3 generations backK112839 Varian High Energy Linear AcceleratorVarian Medical Systems · 2011 · Recalled
- 2 generations backK131807 High Energy Linear AcceleratorVarian Medical Systems, Inc. · 2013 · Recalled
- 1 generation backK162476 Varian High Energy Linear AcceleratorVarian Medical Systems, Inc. · 2016
- This deviceK181404 Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf…Varian Medical Systems, Inc. · 2018
Show all 10 generations
- Root · 10 generations backK913119 Varian C-Series Clinacs (Clinac 2300C/D)Varian Assoc., Inc. · 1991 · Recalled
- 9 generations backK033343 Trilogy Radiotherapy Delivery SystemVarian Medical Systems, Inc. · 2003 · Recalled
- 8 generations backK061140 Trilogy Radiotherapy Delivery SystemVarian Medical Systems · 2006
- 7 generations backK070094 Trilogy Radiotherapy Delivery System and Trilogy TX Delivery SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 6 generations backK072916 Trilogy System with RapidarcVarian Medical Systems, Inc. · 2007 · Recalled
- 5 generations backK081188 Trilogy with External System Gating InterfaceVarian Medical Systems, Inc. · 2008 · Recalled
- 4 generations backK100890 Varian High Energy Linear AcceleratorVarian Medical Systems · 2010 · Recalled
- 3 generations backK112839 Varian High Energy Linear AcceleratorVarian Medical Systems · 2011 · Recalled
- 2 generations backK131807 High Energy Linear AcceleratorVarian Medical Systems, Inc. · 2013 · Recalled
- 1 generation backK162476 Varian High Energy Linear AcceleratorVarian Medical Systems, Inc. · 2016
- This deviceK181404 Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf…Varian Medical Systems, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K913119 | Varian C-Series Clinacs (Clinac 2300C/D) | Varian Assoc., Inc. | 1991 | 6 |
| −9 | K033343 | Trilogy Radiotherapy Delivery System | Varian Medical Systems, Inc. | 2003 | 3 |
| −8 | K061140 | Trilogy Radiotherapy Delivery System | Varian Medical Systems | 2006 | — |
| −7 | K070094 | Trilogy Radiotherapy Delivery System and Trilogy TX Delivery System | Varian Medical Systems, Inc. | 2007 | 5 |
| −6 | K072916 | Trilogy System with Rapidarc | Varian Medical Systems, Inc. | 2007 | 2 |
| −5 | K081188 | Trilogy with External System Gating Interface | Varian Medical Systems, Inc. | 2008 | 1 |
| −4 | K100890 | Varian High Energy Linear Accelerator | Varian Medical Systems | 2010 | 11 |
| −3 | K112839 | Varian High Energy Linear Accelerator | Varian Medical Systems | 2011 | 1 |
| −2 | K131807 | High Energy Linear Accelerator | Varian Medical Systems, Inc. | 2013 | 2 |
| −1 | K162476 | Varian High Energy Linear Accelerator | Varian Medical Systems, Inc. | 2016 | — |
| 0 (this device) | K181404 | Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator | Varian Medical Systems, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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? (3)
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 |
|---|---|---|---|
| * | K162476 | Varian High Energy Linear AcceleratorSummary page 4…ices: Medical Charged Particle Radiation Varian High Energy Linear Accelerator Therapy System, 21 CFR §892.5050 (Version 9.1, K162476) Common/Usual Name: UNIQUE Medical Linear Acc… | 2016 |
| * | K132705 | UniqueSummary page 4…UNIQUE Medical Linear Accelerator (Version 9.1, K132705) Regulatory Class: Class II Product Code: Varian Multileaf… | 2013 |
| * | K133240 | Varian Multileaf CollimatorSummary page 4…Class II Product Code: Varian Multileaf Collimator IYE (Version 8.0, K133240) Page 1 of 4 Device… | 2014 |
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 |
|---|---|---|---|---|
| Aug 12, 2019 | Class II | Z-1899-2020 | Software Design Change | After a recent upgrade to the collimator software version 8.5, the firm became aware that the multi-leaf collimator leaves did not move during an arc treatment. The issue is related to a transient carriage primary- secondary interlock due… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 16 of the 22 ancestors have a recall of any class.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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.
The UNIQUE is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
The Varian Multileaf Collimator is intended to assist the clinician in the delivery of external beam radiation to defined target volumes during radiosurgery and radiotherapy while sparing surrounding normal tissue and critical organs from excess radiation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181404 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181404: Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181404
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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