510(k) · Cleared
ClearedIplan (Iplan Cranial, Iplan Stereotaxy, Iplan Ent, Iplan CMF, Iplan View, Iplan Spine)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainlab AG · JAK System, X-Ray, Tomography, Computed
Cleared on May 7, 2012 as substantially equivalent to K101627 (Brainlab AG, 2011) and 1 other predicate after a 140-day review. Its family tree reaches back 5 generations to 1999. 8 later devices descend from it.
- Decided
- May 7, 2012
- Review
- 140 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K983410 (1999). 13 ancestors in all, the oldest K924810 (1993). 8 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK983410 @ TargetBrainlab AG · 1999
- 4 generations backK020631 IPLANBrainlab AG · 2002
- 3 generations backK041703 IPLAN!Brainlab AG · 2004
- 2 generations backK053127 IPLANBrainlab AG · 2006
- 1 generation backK101627 IPLANBrainlab AG · 2011
- This deviceK113732 Iplan (Iplan Cranial, Iplan Stereotaxy, Iplan Ent, Iplan CMF, Iplan…Brainlab AG · 2012
- Descendant · cites it directly · 5 of its ownK170816 Elements Image Fusion, Elements Cranial Distortion Correction…Brainlab AG · 2017
- Descendant · cites it directly · 3 of its ownK212420 Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements…Brainlab AG · 2021
- Descendant · cites it directly · 1 of its ownK223106 Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion…Brainlab AG · 2023
- Descendant · cites it directly · 1 of its ownK140337 Brightmatter Planning SoftwareSynaptive Medical, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK260576 MeVis AVM ContourMeVis Medical Solutions AG · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG · 2017 · cites it directly5descendants
- K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG · 2021 · cites it directly3descendants
- K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG · 2023 · cites it directly1descendant
- K140337Brightmatter Planning SoftwareSynaptive Medical, Inc. · 2014 · cites it directly1descendant
- K260576MeVis AVM ContourMeVis Medical Solutions AG · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K983410 | @ Target | Brainlab AG | 1999 | — |
| −4 | K020631 | IPLAN | Brainlab AG | 2002 | — |
| −3 | K041703 | IPLAN! | Brainlab AG | 2004 | — |
| −2 | K053127 | IPLAN | Brainlab AG | 2006 | — |
| −1 | K101627 | IPLAN | Brainlab AG | 2011 | — |
| 0 (this device) | K113732 | Iplan (Iplan Cranial, Iplan Stereotaxy, Iplan Ent, Iplan CMF, Iplan View… | Brainlab AG | 2012 | — |
| +1 | K170816 | Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine… | Brainlab AG | 2017 | — |
| +1 | K212420 | Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements… | Brainlab AG | 2021 | — |
| +1 | K223106 | Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion… | Brainlab AG | 2023 | — |
| +1 | K140337 | Brightmatter Planning Software | Synaptive Medical, Inc. | 2014 | — |
| +2 | K260576 | MeVis AVM Contour | MeVis Medical Solutions AG | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1997 | 1 | 0 |
| 2001 | 3 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 JAK? 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 JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 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 |
|---|---|---|---|
| * | K101627 | IPLANSummary page 1…Plan ENT, Plan Spine, Plan View, Plan CMF Common/Classification Name: Planning System, Stereotactic Instrument 3. Predicate Devices iPian (K1 01 627) Maxilim (K052424) 4. Device Description Plan is a software based treatment planning application providing functio… | 2011 |
| * | K052424 | MaxilimSummary page 1…Plan View, Plan CMF Common/Classification Name: Planning System, Stereotactic Instrument 3. Predicate Devices iPian (K1 01 627) Maxilim (K052424) 4. Device Description Plan is a software based treatment planning application providing functionalities like viewing, pr… | 2006 |
What descends from it? (8)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170816 | Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature… | 2017 | 5 |
| K212420 | Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking… | 2021 | 3 |
| K223106 | Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking… | 2023 | 1 |
| K140337 | Brightmatter Planning Software | 2014 | 1 |
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 13 years and passes through 1 company; a new generation was cleared every 2.1 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K170816 (Brainlab AG, 2017) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K101627.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, 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 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
Plan's indications for use are the viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion, atlas assisted visualization and segmentation, intraoperative functional planning where the output can be used e.g. with stereotactic image guided surgery or other devices for further processing and visualization. Example procedures include but are not limited to: - Planning and simulation of…
Read the full statement (145 words)
Plan's indications for use are the viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion, atlas assisted visualization and segmentation, intraoperative functional planning where the output can be used e.g. with stereotactic image guided surgery or other devices for further processing and visualization.
Example procedures include but are not limited to:
- Planning and simulation of cranial surgical procedures such as tumor resection, shunt placement, minimal-invasive stereotactic interventions, biopsy, planning and simulation of trajectories for stimulation and electrode recording
- ENT procedures such as sinus surgery, tumor surgery
- Spine procedures such as tumor surgery, pedicle screw planning, vertebroplasty planning
- Plan View is an application which is intended to be used for reviewing existing treatment plans
- Planning and simulation of cranio-maxillofacial procedures
Typical users of Plan are medical professionals, including but not limited to surgeons and radiologists.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113732 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113732: Iplan (Iplan Cranial, Iplan Stereotaxy, Iplan Ent, Iplan CMF, Iplan View, Iplan Spine).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113732
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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