510(k) · Cleared
Cleared@ Target
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 17, 1999 after a 354-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 of the 345 devices in its family, counting itself, have a Class I recall. 344 later devices descend from it.
- Decided
- Sep 17, 1999
- Review
- 354 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 0
344 later devices descend from it, 1 citing it directly. 3 of the 345 devices in this family, counting this one, have a Class I recall.
- This deviceK983410 @ TargetBrainlab AG · 1999
- Descendant · cites it directly · 343 of its ownK020631 IPLANBrainlab AG · 2002
- Descendant · 2 generations on · 280 of its ownK040050 Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN · 2004 · Recalled (Class I)
- Descendant · 3 generations on · 278 of its ownK053610 AbarisTraxtal Technologies, Inc. · 2006 · Recalled
- Descendant · 4 generations on · 222 of its ownK121498 PercunavPhilips Health Care · 2012
- Descendant · 5 generations on · 211 of its ownK132304 Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
Showing 5 of 344 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 344 · See all- K020631IPLANBrainlab AG · 2002 · cites it directly343descendants
- K040050Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN · 2004 · 2 generations on280descendants
- K053610AbarisTraxtal Technologies, Inc. · 2006 · 3 generations on278descendants
- K121498PercunavPhilips Health Care · 2012 · 4 generations on222descendants
- K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · 5 generations on211descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983410 | @ Target | Brainlab AG | 1999 | — |
| +1 | K020631 | IPLAN | Brainlab AG | 2002 | — |
| +2 | K040050 | Instatrak System with Multiple Dataset Navigation, Model IT3500 | Ge Medical Systems Navigation and Visualization IN | 2004 | Class I |
| +3 | K053610 | Abaris | Traxtal Technologies, Inc. | 2006 | 3 |
| +4 | K121498 | Percunav | Philips Health Care | 2012 | — |
| +5 | K132304 | Epiq Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2013 | 36 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 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 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (344)
See all 3441 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020631 | IPLAN | 2002 | 343 |
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 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 10 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
- K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 10 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K020631 (Brainlab AG, 2002) has gone furthest, with 343 descendants of its own.
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?
SURGERY PLANNING The SURGERY PLANNING module is a tool for pre- and intraopcrative stereotactic swigery planning based on stereotactic systems Multiple graphical digplay functions end 3-dimensional views of anatomical structures offer an effective and efficient means of presenting the anatomical datu for diagnostic and surgical planning. ‘I'he madule provides possibilities to combine and process itage data sets from CT, MRI, Angiographic, and other…
Read the full statement (543 words)
SURGERY PLANNING
The SURGERY PLANNING module is a tool for pre- and intraopcrative stereotactic swigery planning based on stereotactic systems Multiple graphical digplay functions end 3-dimensional views of anatomical structures offer an effective and efficient means of presenting the anatomical datu for diagnostic and surgical planning. ‘I'he madule provides possibilities to combine and process itage data sets from CT, MRI, Angiographic, and other imaging sources. Computcr-graphic simulation in vatious views of a chosen probe path can help prevent probe intersections with unwanted, critical structuies or vessels. The surgeon can interactively change a probe path simulation through the image slices in the workstation with on-line calculation of the accompanying arc settings and graphical manipulation to aid it optimizing his approach. Its modular design makes possible adaption to the uscr’s special requirements,
BRACHYTHERAPY
[tus modula, hased an SURGERY PLANNING, is designed for computergraphic calculation of isodoses from implantation of radloactive seeds. implanted at given positinns within a tumor volume. The radicactive cceda are loaded into catheters tlul are implanted stereotactically. The computer software calilatas the isodose profilcs in various views or in three dimensions prior to actual seed imiplantation. The positioning of the catheters and the indwelling seeds can be dicplaycd in scverel cantours, each perpendicular tu tle direction of the implanted cathetars. The abjective is to better tsilor the dose distribution to the 3 dimensional volume of the tumar. The relevant implantation positions and other paramatars can he printed out for a hardcopy documentation of what has been duie.
BRAINMAP
The BRAINMAP module is a tool, which defines two and thres-dimensional informatian ahout anatomical atructures of the human brain for pre- and intrauperalive planning of stereotactic procedures.. These contours are defined and deecribed by Talairach/Tournoux and/or Schaltenbrand/Wahren based brain utfases,
The user is provided with information about the position of the varioue functional and anatomical areas of the braln. These positions of the structures have to be correlated with every patients brain data.
The conelatiou is delined by a procedure defined by Talalrach/Tournoux. Using their grid systam ta divide the brain in particular areas, the program will be able to provide matching dula fur different patient data. BrainMAP may be used salone or in conjunction with neurosurgery, radiotherapy and radiosurgery planning systems.
FUNCTIONAL PLANNING
The FUNCTIONAL PLANNING Module i3 a tool based on SURGERY PLANNING , which gives two- snd three dimensianal online information of a stereotactical surgical instrument {clectrodcs) for a neurosurgical functional treatment using a stereotactic arc. ihe usar is provided with information by numerical results and by various displays and recunstruction planes based on patient images (CT. MRI, PET, SPECY) about the pasition and orientation relative to the patient of his surgical instrumet tu pet(unin slimulation and treatment on brain structures or to a preplanned trajectory .
Ihe softwara is capahle af displaying the trajectory and functional areas of the brain baced on BRAINMAP online on the screen and recording the stimulations by stoting positians of the electrodes.
The FUNCTIONAL PLANNING nudule is intended to be used with patlents where measurement, stimulation and placement of electrodes in the brain {pallidotomy) are part of the treattuent, The slereotactic arc system s useful for placing these electrodes or using the inctrumente during the treatment and in the planning phases of the functional treatment.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983410 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983410: @ Target.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983410
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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