510(k) · Cleared
Recalled · Class II · 2018Microtargeting Star Drive System, Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
FHC, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Sep 18, 2009 as substantially equivalent to K003776 (FHC, Inc., 2001) after a 29-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it. It has been recalled 9 times.
- Decided
- Sep 18, 2009
- Review
- 29 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 9
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003776 (2001). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K121950Microtargeting XL Star Drive SystemFHC, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003776 | Microtargeting Drive System | FHC, Inc. | 2001 | 4 |
| 0 (this device) | K092562 | Microtargeting Star Drive System, Components | FHC, Inc. | 2009 | — |
| +1 | K121950 | Microtargeting XL Star Drive System | FHC, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 |
|---|---|---|---|
| * | K003776 | Microtargeting Drive SystemSummary page 1…otaxic instrument Classification Name: Stereotaxic instrument (21 CFR 882.4560, Product Code HAW) Substantially Equivalent To: FHC, Inc. microTargeting TM Drive System K003776, February 23, 2001 Description: When used in conjunction with commonly available stereotactic systems, the microTa… | 2001 |
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 |
|---|---|---|---|
| K121950 | Microtargeting XL Star Drive System | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 10, 2018 | Class II | Z-2357-2018 | Device Design | The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the… |
| May 10, 2018 | Class II | Z-2349-2018 | Device Design | The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the… |
| May 10, 2018 | Class II | Z-2351-2018 | Device Design | The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the… |
| May 10, 2018 | Class II | Z-2358-2018 | Device Design | The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the… |
| May 10, 2018 | Class II | Z-2352-2018 | Device Design | The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the… |
| May 10, 2018 | Class II | Z-2354-2018 | Device Design | The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the… |
| May 10, 2018 | Class II | Z-2350-2018 | Device Design | The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the… |
| Mar 30, 2010 | Not classified | Z-0314-2011 | Device Design | Fixation thumbscrew on the DBS depth stop adapter may be overtightened and damage the implantable lead. |
| Mar 30, 2010 | Not classified | Z-0312-2011 | Device Design | Fixation thumbscrew on the DBS depth stop adapter may be overtightened and damage the implantable lead. |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a 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. 2009, 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?
The FHC microTargetingTM STar DriveTM System is intended to be used with commercially available positioning systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092562 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092562: Microtargeting Star Drive System, Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092562
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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