510(k) · Cleared
Recalled · 2009M3 (Mirco-Multileaf Collimator
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 Mar 26, 2002 after a 454-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 26, 2002
- Review
- 454 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 2
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK004022 M3 (Mirco-Multileaf CollimatorBrainlab AG · 2002
- Descendant · cites it directly · 4 of its ownK020860 M3 (Micro-Multileaf Collimator)Brainlab AG · 2002 · Recalled
- Descendant · cites it directly · 1 of its ownK060187 Topslane DMLCTopslane International, LLC · 2006
- Descendant · 2 generations on · 1 of its ownK052705 DART-12Direx Systems Corp. · 2006
- Descendant · 2 generations on · 0 of its ownK090802 Tigrt MLC, Tigrt DMLCLinatech, LLC · 2009
- Descendant · 3 generations on · 0 of its ownK071701 Trackleaf-10Direx Systems Corp. · 2007
Most influential descendants
Showing 5 of 5 · See all- K020860M3 (Micro-Multileaf Collimator)Brainlab AG · 2002 · cites it directly4descendants
- K060187Topslane DMLCTopslane International, LLC · 2006 · cites it directly1descendant
- K052705DART-12Direx Systems Corp. · 2006 · 2 generations on1descendant
- K090802Tigrt MLC, Tigrt DMLCLinatech, LLC · 2009 · 2 generations on0descendants
- K071701Trackleaf-10Direx Systems Corp. · 2007 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K004022 | M3 (Mirco-Multileaf Collimator | Brainlab AG | 2002 | — |
| +1 | K020860 | M3 (Micro-Multileaf Collimator) | Brainlab AG | 2002 | 1 |
| +1 | K060187 | Topslane DMLC | Topslane International, LLC | 2006 | — |
| +2 | K052705 | DART-12 | Direx Systems Corp. | 2006 | — |
| +2 | K090802 | Tigrt MLC, Tigrt DMLC | Linatech, LLC | 2009 | — |
| +3 | K071701 | Trackleaf-10 | Direx Systems Corp. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 19, 2009 | Not classified | Z-1547-2009 | Other | The Integrated Multileaf-Collimator (MLC) of the linear accelerator could interfere with the intended conformal fields of the BrainLab m3 micro-Multileaf-Collimator (mMLC) during patient treatment. |
| Mar 19, 2009 | Not classified | Z-1545-2009 | Other | The Integrated Multileaf-Collimator (MLC) of the linear accelerator could interfere with the intended conformal fields of the BrainLab m3 micro-Multileaf-Collimator (mMLC) during patient treatment. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K020860 (Brainlab AG, 2002) 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.
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 | — |
https://510kreport.com/device/K004022 · printed Nov 4, 2026
Cite this page
510(k) Report. “K004022: M3 (Mirco-Multileaf Collimator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K004022
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026