510(k) · Cleared
Recalled · Class II · 2018FHC Microtargeting Drive System
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 Aug 14, 2001 as substantially equivalent to K003776 (FHC, Inc., 2001) after a 49-day review. Its family tree reaches back 1 generation to 2001. It has been recalled 6 times.
- Decided
- Aug 14, 2001
- Review
- 49 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003776 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK003776 Microtargeting Drive SystemFHC, Inc. · 2001 · Recalled
- This deviceK011992 FHC Microtargeting Drive SystemFHC, Inc. · 2001
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) | K011992 | FHC Microtargeting Drive System | FHC, Inc. | 2001 | — |
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 2…tic Instrument HAW Il 882.4560 11 C. Identification of Legally Marketed Devices Name K Number Date Cleared 1. FHC, Inc microTargeting® Drive System K003776 Feb. 23, 2001 D. Description of Device The microTargeting® Drive System with permits the accurate positioning of microelectrode… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
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-2353-2018 | 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-2359-2018 | 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… |
| Oct 8, 2008 | Not classified | Z-0486-2009 | Process control | Measuring fixture is incorrectly graduated. |
| Oct 31, 2005 | Not classified | Z-0179-06 | Other | Power Assist microTargeting System may advance beyond intended target |
| Oct 31, 2005 | Not classified | Z-0180-06 | Other | Power Assist microTargeting System may advance beyond intended target |
| Mar 14, 2005 | Not classified | Z-0895-05 | Other | Potential for non-sterile pin to contaminate sterile field |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 3 other devices also cite its predicate K003776.
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?
The FHC microTargeting® Drive System is intended to be used with commercially available stereotactic 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011992 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011992: FHC Microtargeting Drive System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011992
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026