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 Sep 9, 2002 as substantially equivalent to K003589 (Brainlab AG, 2001) and 3 other predicates after a 194-day review. Its family tree reaches back 1 generation to 1999. 3 of the 348 devices in its family, counting itself, have a Class I recall. 343 later devices descend from it.
- Decided
- Sep 9, 2002
- Review
- 194 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K983410 (1999). 4 ancestors in all. 343 later devices descend from it, 5 citing it directly. 3 of the 348 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK983410 @ TargetBrainlab AG · 1999
- This deviceK020631 IPLANBrainlab AG · 2002
- Descendant · cites it directly · 280 of its ownK040050 Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN · 2004 · Recalled (Class I)
- Descendant · 2 generations on · 278 of its ownK053610 AbarisTraxtal Technologies, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 222 of its ownK121498 PercunavPhilips Health Care · 2012
- Descendant · 4 generations on · 211 of its ownK132304 Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
- Descendant · 5 generations on · 100 of its ownK160807 EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound…Philips Ultrasound, Inc. · 2016 · Recalled
Showing 5 of 343 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 343 · See all- K040050Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN · 2004 · cites it directly280descendants
- K053610AbarisTraxtal Technologies, Inc. · 2006 · 2 generations on278descendants
- K121498PercunavPhilips Health Care · 2012 · 3 generations on222descendants
- K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · 4 generations on211descendants
- K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc. · 2016 · 5 generations on100descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983410 | @ Target | Brainlab AG | 1999 | — |
| 0 (this device) | K020631 | IPLAN | Brainlab AG | 2002 | — |
| +1 | K040050 | Instatrak System with Multiple Dataset Navigation, Model IT3500 | Ge Medical Systems Navigation and Visualization IN | 2004 | Class I |
| +2 | K053610 | Abaris | Traxtal Technologies, Inc. | 2006 | 3 |
| +3 | K121498 | Percunav | Philips Health Care | 2012 | — |
| +4 | K132304 | Epiq Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2013 | 36 |
| +5 | K160807 | EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System… | Philips Ultrasound, Inc. | 2016 | 33 |
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 |
|---|---|---|
| 2004 | 4 | 1 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 5 | 0 |
| 2013 | 5 | 0 |
| 2014 | 12 | 0 |
| 2015 | 17 | 0 |
| 2016 | 18 | 0 |
| 2017 | 35 | 0 |
| 2018 | 22 | 0 |
| 2019 | 18 | 0 |
| 2020 | 29 | 0 |
| 2021 | 32 | 0 |
| 2022 | 25 | 0 |
| 2023 | 24 | 0 |
| 2024 | 20 | 0 |
| 2025 | 35 | 2 |
| 2026 | 26 | 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.
3 devices in this family have a Class I recall. 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? (4)
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 |
|---|---|---|---|
| * | K003589 | Vectorvision Cranial, Vectorvision Spinal, Vectorvision EntSummary page 1…Man[ Comman/Classification Name: Planning Systern/Stereotaxic Instrument Predicate Devices: Vector Vision@'Z Cranial, Spine, ENT (K 003589) Vector Vision@2 Hip (K 010602) Vector Visiona 2 Knee (K 01061 2) @target@… | 2001 |
| * | K010602 | Vectorvision HipSummary page 1…Planning Systern/Stereotaxic Instrument Predicate Devices: Vector Vision@'Z Cranial, Spine, ENT (K 003589) Vector Vision@2 Hip (K 010602) Vector Visiona 2 Knee (K 01061 2) @target@ {K 983410) Device Classifica… | 2001 |
| * | K010612 | Vectorvision KneeSummary page 1…redicate Devices: Vector Vision@'Z Cranial, Spine, ENT (K 003589) Vector Vision@2 Hip (K 010602) Vector Visiona 2 Knee (K 01061 2) @target@ {K 983410) Device Classification Name: Instrument, Stereotaxic Regulatory Class: Cl… | 2001 |
| * | K983410 | @ TargetSummary page 1…(K 003589) Vector Vision@2 Hip (K 010602) Vector Visiona 2 Knee (K 01061 2) @target@ {K 983410) Device Classification Name: Instrument, Stereotaxic Regulatory Class: Class il… | 1999 |
What descends from it? (343)
See all 3435 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K040050Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN · 2004 · Cites it directly · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 9 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
- K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 9 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
iPlan!'s indications for use is to prepare and present patient and image data based on CT, MR, X-ray(Fluoro), including - image preparation - image fusion - image segmentation where the result is used for the creation of treatment plans for Stsreotactic Surgery: -Suraery Planning The Surgery Planning is a tool for pre- and intraoperative stereotactic surgery planning based on stereotactic systems. Multiple graphical display functions and 3-dimensional…
Read the full statement (590 words)
iPlan!'s indications for use is to prepare and present patient and image data based on CT, MR, X-ray(Fluoro), including
- image preparation
- image fusion
- image segmentation
where the result is used for the creation of treatment plans for Stsreotactic Surgery:
-Suraery Planning
The Surgery Planning is a tool for pre- and intraoperative stereotactic surgery planning based on stereotactic systems. Multiple graphical display functions and 3-dimensional views of anatomical structures offer effective and efficient means of presenting the anatomical data far diagnostic and surgical planning. Computer-graphic simulation in vanous views of a chosen probe path can help prevent probe intersections with unwanted, critical structures or vasseis,
The surgeon can interactively change a probe path simulation through the image slices in the software with on-line calculation of the accompanying arc settings and graphical manipulation to aid in optimizlng his approach.
- BrainMAP
The BrainMAP module is a tool, which defines two and three-dimensional information about anatomical structures of the human brain for pre- and intraoperative planning of stereotactic procedures. These contours are defined and described by Talairacflournoux andfar SchaltenbranWahren based brain atlases.
The user is provided &ith information about the position of the various functional and anatamical areas of the brain. These positions of the structures have to be carrelated with every patients brain data. The correlation is defined by a procedure defined by TalairacNTournoux. Using their grid system to divide the brain in particular areas, the program will be able to provide matching data for different patient data, BrainMAP may be used alone or in conjunction with neurosurgery.
- Functional Planning
The FunctionalPlanning is based on Surgery Planning, which gives two- and three dimensional online information of a stereotactical surgical instrument (electrodes) for a neurosurgical functional treatment using a stereotactic arc. The user is provided with information by numerical results and by various displays and rkmstruction planes based on patient lrnages (CT, MRI, PET, SPECT) about the position and orientation relative to the patient of his surgical instrument to perform stimulation and treatment on brain structures or to a preplanned trajectory .
The software is capable of displaying the tmjectoly and functional areas of the brain based on BrainMAP online on the screen and recording the stimulations by storing positions of the electrodes.
The Functional Planning is intended to be used w'&h patients where rneesurement, stimulation and placement of electrodes in the brain (pallidotomy] are part of the treatment. The stereotactic arc system is useful for placing these electrodes or using the instruments during the treatment and in the planning phases of the functional treatment,
In addition iPlan!'s indications for use is to prepare and present patient and image data based on CT, MR, X-ray(Fluoro) includinq
- image preparation
- image fusion
- image segmentation
where the result is preplanned data to be used by other BrainLAB medical devices such as VectorVision (for performing the planned treatment) where these medical devices are used for:
Image Guided Surgery
BrainLAB's Image Guided Surgery system is intended to be an intraoperative image guided localization systtilrn t o enable minimally invasive surgery where the image guided surgery system is indicated for any medical condition in which the use of stereotactic surgery may be considered to be appropriate and where B reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, X-ray or MR based model of the anatomy.
Exampte procedures include but are not limited to:
- Cranial procedures
- Spine procedures
- ENT procedures
- Hip procedures
- Knee procedures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020631 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020631: IPLAN.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020631
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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