510(k) · Cleared
ClearedIdentify (5.0)
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 Dec 16, 2025 as substantially equivalent to K242957 (Varian Medical Systems, Inc., 2025) after a 95-day review. Its family tree reaches back 8 generations to 2001.
- Decided
- Dec 16, 2025
- Review
- 95 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K003285 (2001). No later device cites it as a predicate yet.
- Root · 8 generations backK003285 Exac Trac 2.0 (Novalis Body Module)Brainlab AG · 2001
- 7 generations backK062611 Iguide SystemMedical Intelligence Medizintechnik-GmbH-An Elekta · 2006
- 6 generations backK112692 IdentifyHumediq GmbH · 2012
- 5 generations backK190137 IdentifyVarian Medical Systems, Inc. · 2019
- 4 generations backK192968 IdentifyVarian Medical Systems, Inc. · 2019
- 3 generations backK210835 IdentifyVarian Medical Systems, Inc. · 2021
- 2 generations backK230576 IdentifyVarian Medical Systems, Inc. · 2023
- 1 generation backK242957 Identify (4.0)Varian Medical Systems, Inc. · 2025
- This deviceK252919 Identify (5.0)Varian Medical Systems, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K003285 | Exac Trac 2.0 (Novalis Body Module) | Brainlab AG | 2001 | — |
| −7 | K062611 | Iguide System | Medical Intelligence Medizintechnik-GmbH-An Elekta | 2006 | — |
| −6 | K112692 | Identify | Humediq GmbH | 2012 | — |
| −5 | K190137 | Identify | Varian Medical Systems, Inc. | 2019 | — |
| −4 | K192968 | Identify | Varian Medical Systems, Inc. | 2019 | — |
| −3 | K210835 | Identify | Varian Medical Systems, Inc. | 2021 | — |
| −2 | K230576 | Identify | Varian Medical Systems, Inc. | 2023 | — |
| −1 | K242957 | Identify (4.0) | Varian Medical Systems, Inc. | 2025 | — |
| 0 (this device) | K252919 | Identify (5.0) | Varian Medical Systems, Inc. | 2025 | — |
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 |
|---|---|---|---|
| * | K242957 | Identify (4.0)Summary page 5…cal Product Code: IYE Common Name: Patient identification & positioning/tracking system III. Predicate Device Proprietary Name: IDENTIFY 4.0 (K242957) Regulation Number: 21 CFR §892.5050 Classification Name: Accelerator, linear, medical Product Code: IYE… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- None of the 8 ancestors has a recall.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
IDENTIFY is indicated for adult patients undergoing radiotherapy treatment simulation and/or delivery. IDENTIFY is indicated for positioning of patients, and for monitoring patient motion including respiratory patterns. It allows for data output to radiotherapy devices to synchronize image acquisition or treatment delivery with the acquired motion information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252919 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252919: Identify (5.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252919
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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