510(k) Report

510(k) · Cleared

Cleared

@ Target

K983410510(k) TraditionalCleared Sep 17, 1999354-day reviewClass II21 CFR 882.4560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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.

Descendants, by year cleared 2002: 1 descendant cleared2005: 2 descendants cleared2004: 4 descendants cleared, 1 with a Class I recall12008: 3 descendants cleared2006: 3 descendants cleared2009: 4 descendants cleared2011: 3 descendants cleared2021: 32 descendants cleared2014: 12 descendants cleared2012: 5 descendants cleared2015: 17 descendants cleared2013: 5 descendants cleared2010: 1 descendant cleared2016: 18 descendants cleared2017: 35 descendants cleared2018: 22 descendants cleared2023: 24 descendants cleared2020: 29 descendants cleared2019: 18 descendants cleared2026: 26 descendants cleared2022: 25 descendants cleared2024: 20 descendants cleared2025: 35 descendants cleared, 2 with a Class I recall21995200020052010201520202025
  1. This deviceK983410 @ TargetBrainlab AG · 1999
  2. Descendant · cites it directly · 343 of its ownK020631 IPLANBrainlab AG · 2002
  3. 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)
  4. Descendant · 3 generations on · 278 of its ownK053610 AbarisTraxtal Technologies, Inc. · 2006 · Recalled
  5. Descendant · 4 generations on · 222 of its ownK121498 PercunavPhilips Health Care · 2012
  6. 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

2002: 12004: 42005: 22006: 32008: 32009: 42010: 12011: 32012: 52013: 52014: 122015: 172016: 182017: 352018: 222019: 182020: 292021: 322022: 252023: 242024: 202025: 352026: 26
2002high 35 (2017) · low 0 (2003)2026

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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K983410@ TargetBrainlab AG1999—
+1K020631IPLANBrainlab AG2002—
+2K040050Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN2004Class I
+3K053610AbarisTraxtal Technologies, Inc.20063
+4K121498PercunavPhilips Health Care2012—
+5K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201336

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200441
200520
200630
200830
200940
201010
201130
201250
201350
2014120
2015170
2016180
2017350
2018220
2019180
2020290
2021320
2022250
2023240
2024200
2025352
2026260
FIG. 1 — Lineage of K983410, 1999–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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 344

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K020631IPLANBrainlab AG2002343

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 devices

HAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HAW

9in 2025

2007: 152008: 122009: 82010: 62011: 42012: 82013: 32014: 52015: 102016: 92017: 72018: 62019: 102020: 52021: 92022: 72023: 142024: 72025: 92026 (partial year): 5
2007high 15 (2007) · low 3 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HAW

163in 2025

2007: 107 days median2008: 112 days median2009: 221 days median2010: 138 days median2011: 66 days median2012: 178 days median2013: 172 days median2014: 238 days median2015: 232 days median2016: 175 days median2017: 226 days median2018: 112 days median2019: 147 days median2020: 88 days median2021: 168 days median2022: 128 days median2023: 142 days median2024: 107 days median2025: 163 days median2026 (partial year): 162 days median
2007high 238 (2014) · low 66 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HAW

2in 2025

2007: 22008: 102009: 62010: 282011: 52012: 42013: 6, 1 Class I2014: 52015: 32016: 52017: 22018: 2, 2 Class I2019: 4, 1 Class I2020: 12021: 4, 2 Class I2022: 12023: 4, 1 Class I2024: 2, 2 Class I2025: 22026 (partial year): 6
2007high 28 (2010) · low 1 (2020)2026

Class I (9 since 2007) Class II/III not classified

Adverse event reports per year · HAW

3,425in 2025

2007: 492008: 532009: 962010: 2992011: 1,7252012: 9862013: 1,2902014: 1,6062015: 1,7672016: 1,8282017: 3,5052018: 4,4392019: 6,0622020: 3,4802021: 2,8272022: 1,9292023: 2,5102024: 3,7552025: 3,425
2007high 6,062 (2019) · low 49 (2007)2025

MAUDE reports naming product code HAW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200715107249
2008121121053
20098221696
2010613828299
201146651,725
201281784986
201331726 (1)1,290
2014523851,606
20151023231,767
2016917551,828
2017722623,505
201861122 (2)4,439
2019101474 (1)6,062
202058813,480
202191684 (2)2,827
2022712811,929
2023141424 (1)2,510
202471072 (2)3,755
2025916323,425
202651626—

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.

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