510(k) · Cleared
ClearedNavigation Marker, Reflective Marker Spheres
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ilumark GmbH · HAW Neurological Stereotaxic Instrument
Cleared on Feb 7, 2011 as substantially equivalent to K033621 (Northern Digital, Inc., 2004) and 1 other predicate after a 101-day review. Its family tree reaches back 5 generations to 1999. 1 later device descends from it.
- Decided
- Feb 7, 2011
- Review
- 101 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K983831 (1999). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 4 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 3 generations backK042391 Kolibri Image Guided Surgery SystemBrainlab AG · 2004
- 2 generations backK082060 Cranial Image Guided Surgery SystemBrainlab AG · 2009
- 1 generation backK100038 Disposable Reflective Marker SpheresBrainlab AG · 2010 · Recalled
- This deviceK103192 Navigation Marker, Reflective Marker SpheresIlumark GmbH · 2011
- Descendant · cites it directly · 0 of its ownK111443 X12 Sterile Reflective Marker SpherePinsco Inc. Dba B & L Engineering · 2011
Most influential descendants
Showing 1 of 1 · See all- K111443X12 Sterile Reflective Marker SpherePinsco Inc. Dba B & L Engineering · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −4 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −3 | K042391 | Kolibri Image Guided Surgery System | Brainlab AG | 2004 | — |
| −2 | K082060 | Cranial Image Guided Surgery System | Brainlab AG | 2009 | — |
| −1 | K100038 | Disposable Reflective Marker Spheres | Brainlab AG | 2010 | 3 |
| 0 (this device) | K103192 | Navigation Marker, Reflective Marker Spheres | Ilumark GmbH | 2011 | — |
| +1 | K111443 | X12 Sterile Reflective Marker Sphere | Pinsco Inc. Dba B & L Engineering | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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? (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 |
|---|---|---|---|
| * | K033621 | Ndi Passive SpheresSummary page 1…design, dimensional and materials characterization to other legally marketed devices from different manufacturers, e.g. NDl passive Spheres from Northern Digital Inc., #K033621 and Disposable Reflective Marker Spheres from BrainLAB Ag #K1 00038. IK A0250kSu naqyvl .doc R.v. 1… | 2004 |
| * | K100038 | Disposable Reflective Marker SpheresSummary page 1…y marketed devices from different manufacturers, e.g. NDl passive Spheres from Northern Digital Inc., #K033621 and Disposable Reflective Marker Spheres from BrainLAB Ag #K1 00038. IK A0250kSu naqyvl .doc R.v. 1,0 Page1 of 2 === Page 2 ==… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111443 | X12 Sterile Reflective Marker Sphere | 2011 | 0 |
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 2 companies; a new generation was cleared every 2.3 years on median.
- 4 of the 10 ancestors have a recall of any class.
- Of its descendants, K111443 (Pinsco Inc. Dba B & L Engineering, 2011) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K033621.
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?
ILUMARK Navigation Markers are intended to be used as image guided surgery system accessory to aid in auto-registration and localization of rigid patient anatomical structure in either open or percutaneous image guided surgery procedures. It is indicated for any medical condition in which the use of an image guided surgery system may be considered to be dppropriate.
ILUMARK Navigation Markers can be used in following procedures:
* Stereotactic brain surgery
* Endoscopic Sinus Surgery
* Pedicle Screw Placement
* Reconstructive orthopedic surgery
* Soft tissue treatment
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103192 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103192: Navigation Marker, Reflective Marker Spheres.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103192
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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