510(k) · Cleared
ClearedIPLAN
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainlab AG · HAW Neurological Stereotaxic Instrument
Cleared on Jun 3, 2011 as substantially equivalent to K053127 (Brainlab AG, 2006) after a 359-day review. Its family tree reaches back 4 generations to 1999. 12 later devices descend from it.
- Decided
- Jun 3, 2011
- Review
- 359 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K983410 (1999). 7 ancestors in all. 12 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK983410 @ TargetBrainlab AG · 1999
- 3 generations backK020631 IPLANBrainlab AG · 2002
- 2 generations backK041703 IPLAN!Brainlab AG · 2004
- 1 generation backK053127 IPLANBrainlab AG · 2006
- This deviceK101627 IPLANBrainlab AG · 2011
- Descendant · cites it directly · 8 of its ownK113732 Iplan (Iplan Cranial, Iplan Stereotaxy, Iplan Ent, Iplan CMF, Iplan…Brainlab AG · 2012
- Descendant · 2 generations on · 5 of its ownK170816 Elements Image Fusion, Elements Cranial Distortion Correction…Brainlab AG · 2017
- Descendant · 2 generations on · 3 of its ownK212420 Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements…Brainlab AG · 2021
- Descendant · 2 generations on · 1 of its ownK223106 Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion…Brainlab AG · 2023
- Descendant · cites it directly · 1 of its ownK211544 Trajectory Planning, Elements Trajectory Planning, Elements Lead…Brainlab AG · 2021
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K113732Iplan (Iplan Cranial, Iplan Stereotaxy, Iplan Ent, Iplan CMF, Iplan View, Iplan Spine)Brainlab AG · 2012 · cites it directly8descendants
- K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG · 2017 · 2 generations on5descendants
- K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG · 2021 · 2 generations on3descendants
- K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG · 2023 · 2 generations on1descendant
- K211544Trajectory Planning, Elements Trajectory Planning, Elements Lead LocalizationBrainlab AG · 2021 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K983410 | @ Target | Brainlab AG | 1999 | — |
| −3 | K020631 | IPLAN | Brainlab AG | 2002 | — |
| −2 | K041703 | IPLAN! | Brainlab AG | 2004 | — |
| −1 | K053127 | IPLAN | Brainlab AG | 2006 | — |
| 0 (this device) | K101627 | IPLAN | Brainlab AG | 2011 | — |
| +1 | K113732 | Iplan (Iplan Cranial, Iplan Stereotaxy, Iplan Ent, Iplan CMF, Iplan View… | Brainlab AG | 2012 | — |
| +2 | K170816 | Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine… | Brainlab AG | 2017 | — |
| +2 | K212420 | Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements… | Brainlab AG | 2021 | — |
| +2 | K223106 | Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion… | Brainlab AG | 2023 | — |
| +1 | K211544 | Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization | Brainlab AG | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 2 | 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 HAW? 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 HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 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 |
|---|---|---|---|
| * | K053127 | IPLANSummary page 1…Plan ENT, iPlan Spine, iPlan View Common/Classification Name: Planning System, Stereotactic Instrument Predicate Device: iPlan (K053127) Device Classification Name: Instrument, Stereotaxic Regulatory Class: Class 11 Indications For Use: Plan's indications for us… | 2006 |
What descends from it? (12)
See all 123 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)
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 12 years and passes through 1 company; a new generation was cleared every 3.0 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K113732 (Brainlab AG, 2012) has gone furthest, with 8 descendants of its own.
- 3 other devices also cite its predicate K053127.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, 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 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
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 eg. 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 (138 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 eg. 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 pilacement, 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, pedlicle screw planning, vertebroplasty planning
- Plan View is an application which is intended to be used for reviewing existing treatment plans
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/K101627 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101627: IPLAN.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101627
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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