510(k) · Cleared
ClearedIdentify
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 Jul 10, 2019 as substantially equivalent to K112692 (Humediq GmbH, 2012) after a 162-day review. Its family tree reaches back 3 generations to 2001. 5 later devices descend from it.
- Decided
- Jul 10, 2019
- Review
- 162 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K003285 (2001). 5 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK003285 Exac Trac 2.0 (Novalis Body Module)Brainlab AG · 2001
- 2 generations backK062611 Iguide SystemMedical Intelligence Medizintechnik-GmbH-An Elekta · 2006
- 1 generation backK112692 IdentifyHumediq GmbH · 2012
- This deviceK190137 IdentifyVarian Medical Systems, Inc. · 2019
- Descendant · cites it directly · 4 of its ownK192968 IdentifyVarian Medical Systems, Inc. · 2019
- Descendant · 2 generations on · 3 of its ownK210835 IdentifyVarian Medical Systems, Inc. · 2021
- Descendant · 3 generations on · 2 of its ownK230576 IdentifyVarian Medical Systems, Inc. · 2023
- Descendant · 4 generations on · 1 of its ownK242957 Identify (4.0)Varian Medical Systems, Inc. · 2025
- Descendant · 5 generations on · 0 of its ownK252919 Identify (5.0)Varian Medical Systems, Inc. · 2025
Most influential descendants
Showing 5 of 5 · See all- K192968IdentifyVarian Medical Systems, Inc. · 2019 · cites it directly4descendants
- K210835IdentifyVarian Medical Systems, Inc. · 2021 · 2 generations on3descendants
- K230576IdentifyVarian Medical Systems, Inc. · 2023 · 3 generations on2descendants
- K242957Identify (4.0)Varian Medical Systems, Inc. · 2025 · 4 generations on1descendant
- K252919Identify (5.0)Varian Medical Systems, Inc. · 2025 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003285 | Exac Trac 2.0 (Novalis Body Module) | Brainlab AG | 2001 | — |
| −2 | K062611 | Iguide System | Medical Intelligence Medizintechnik-GmbH-An Elekta | 2006 | — |
| −1 | K112692 | Identify | Humediq GmbH | 2012 | — |
| 0 (this device) | K190137 | Identify | Varian Medical Systems, Inc. | 2019 | — |
| +1 | K192968 | Identify | Varian Medical Systems, Inc. | 2019 | — |
| +2 | K210835 | Identify | Varian Medical Systems, Inc. | 2021 | — |
| +3 | K230576 | Identify | Varian Medical Systems, Inc. | 2023 | — |
| +4 | K242957 | Identify (4.0) | Varian Medical Systems, Inc. | 2025 | — |
| +5 | K252919 | Identify (5.0) | Varian Medical Systems, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K112692 | IdentifySummary page 4…, IYE, Class II Common/Usual Name: Patient identification & positioning/tracking system Predicate Device: Identify (K112692) Device Description: Identify is used for patient‐setup, guidance and to monitor a patient before… | 2012 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192968 | Identify | 2019 | 4 |
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 18 years and passes through 4 companies; a new generation was cleared every 5.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K192968 (Varian Medical Systems, Inc., 2019) has gone furthest, with 4 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. 2019, 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 patient and accessory identification, positioning and tracking for imaging and radiation therapy treatments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190137 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190137: Identify.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190137
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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