510(k) · Cleared
ClearedExactrac Gating
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainlab AG · IYE Accelerator, Linear, Medical
Cleared on Dec 19, 2003 as substantially equivalent to K003285 (Brainlab AG, 2001) and 1 other predicate after a 66-day review. Its family tree reaches back 2 generations to 1987. 16 later devices descend from it.
- Decided
- Dec 19, 2003
- Review
- 66 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K864886 (1987). 3 ancestors in all. 16 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK864886 Respigraph-Respisomnograph-RespicentralNims/Respitrace Corp. · 1987
- 1 generation backK983629 RPM Respiratory Gating SystemVarian Medical Systems, Inc. · 1999
- This deviceK033287 Exactrac GatingBrainlab AG · 2003
- Descendant · cites it directly · 15 of its ownK072506 Exactrac 5.5Brainlab AG · 2007 · Recalled
- Descendant · 2 generations on · 8 of its ownK120789 Exactrac X-Ray X-RayBrainlab AG · 2012 · Recalled
- Descendant · 3 generations on · 6 of its ownK201276 ExacTrac DynamicBrainlab AG · 2020 · Recalled
- Descendant · 2 generations on · 5 of its ownK080742 Verisuite 1.6, Verisuite-Particle 1.6Medcom GmbH · 2008
- Descendant · 4 generations on · 3 of its ownK220338 ExacTrac DynamicBrainlab AG · 2022 · Recalled
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K072506Exactrac 5.5Brainlab AG · 2007 · cites it directly15descendants
- K120789Exactrac X-Ray X-RayBrainlab AG · 2012 · 2 generations on8descendants
- K201276ExacTrac DynamicBrainlab AG · 2020 · 3 generations on6descendants
- K080742Verisuite 1.6, Verisuite-Particle 1.6Medcom GmbH · 2008 · 2 generations on5descendants
- K220338ExacTrac DynamicBrainlab AG · 2022 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K864886 | Respigraph-Respisomnograph-Respicentral | Nims/Respitrace Corp. | 1987 | — |
| −1 | K983629 | RPM Respiratory Gating System | Varian Medical Systems, Inc. | 1999 | — |
| 0 (this device) | K033287 | Exactrac Gating | Brainlab AG | 2003 | — |
| +1 | K072506 | Exactrac 5.5 | Brainlab AG | 2007 | 1 |
| +2 | K120789 | Exactrac X-Ray X-Ray | Brainlab AG | 2012 | 6 |
| +3 | K201276 | ExacTrac Dynamic | Brainlab AG | 2020 | 1 |
| +2 | K080742 | Verisuite 1.6, Verisuite-Particle 1.6 | Medcom GmbH | 2008 | — |
| +4 | K220338 | ExacTrac Dynamic | Brainlab AG | 2022 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K003285 | Exac Trac 2.0 (Novalis Body Module)Summary page 1…th, 2003 Device Name: Trade name: ExacTrac® Gating Common/Classification Name: ExacTrac® Gating Predicate Devices: ExacTrac® (K003285) RPM Respiratory Gating System (K983629) Device Classification Name: Instrument, Regulatory Class: Class II In… | 2001 |
| * | K983629 | RPM Respiratory Gating SystemSummary page 1…ExacTrac® Gating Common/Classification Name: ExacTrac® Gating Predicate Devices: ExacTrac® (K003285) RPM Respiratory Gating System (K983629) Device Classification Name: Instrument, Regulatory Class: Class II Intended Use: The ExacTrac gating module… | 1999 |
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072506 | Exactrac 5.5 | 2007 | 15 |
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 16 years and passes through 3 companies; a new generation was cleared every 12.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K072506 (Brainlab AG, 2007) has gone furthest, with 15 descendants of its own.
- 5 other devices also cite its predicate K003285.
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 | — |
What is it indicated for?
The ExacTrac gating module is an extension to the ExacTrac patient positioning system. ExacTrac Gating repositions the patient relative to the treatment machine according to breathing induced shifts of a target area, and controls the gating of the treatment beam.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033287 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033287: Exactrac Gating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033287
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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