510(k) · Cleared
Recalled · Class I · 2024Micro Targeting 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 30, 2001 as substantially equivalent to K003776 (FHC, Inc., 2001) and 3 other predicates after an 84-day review. Its family tree reaches back 2 generations to 1981. 1 of the 7 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 8 times, including a Class I recall.
- Decided
- Aug 30, 2001
- Review
- 84 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 8 (1 Class I)
- Predicates
- 4
Its longest line of descent runs back 2 generations to K811452 (1981). 5 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 7 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK811452 Brown-Roberts-Wells Stereotaxic SytemTrent Wells, Inc. · 1981
- 1 generation backK990683 Axon MP-1 MicropositionerAxon Instruments, Inc. · 1999
- This deviceK011775 Micro Targeting Drive SystemFHC, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK040979 Elekta Microdrive, Model 916716Elekta Instrument AB · 2004
Most influential descendants
Showing 1 of 1 · See all- K040979Elekta Microdrive, Model 916716Elekta Instrument AB · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K811452 | Brown-Roberts-Wells Stereotaxic Sytem | Trent Wells, Inc. | 1981 | — |
| −1 | K990683 | Axon MP-1 Micropositioner | Axon Instruments, Inc. | 1999 | — |
| 0 (this device) | K011775 | Micro Targeting Drive System | FHC, Inc. | 2001 | — |
| +1 | K040979 | Elekta Microdrive, Model 916716 | Elekta Instrument AB | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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.
1 device in this family has 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? (4)
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…drive System Stereotactic Instrument HAW i 882.4560 C. Identification of Legally Marketed Devices Name ‘ K Number 1. FHC microTargeting® Drive System K003776 2. Axon Instruments MP-1 Micropaositioner K99068 3. Radionics CRW-FMD Kgo2721 4. MSC pEEG uDrive Model 25/50 K991077 D. Descr… | 2001 |
| * | K990683 | Axon MP-1 MicropositionerSummary page 3…Targeting® Drive System is substantially equivalent to the FHC, Inc. microTargeting® Drive System (K003776), Axon Instruments Guideline System 3000 MP-1 Micropositioner (K990683), the Radionics Cosman Robett Wells Functional Probe Microdrive (CRW-FMD) (K292721) and the Microrecording System Consultants uEE… | 1999 |
| * | K992721 | Cosman Robert Wells Functional Probe Microdrive Our OCR of the scanned summary read K292721, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Radionics Cosman Robett Wells Functional Probe Microdrive (CRW-FMD)”. | 1999 |
| * | K991077 | Microelectroencephalography Professional System 5000 (Eeg Pro System 5000)Summary page 2…me ‘ K Number 1. FHC microTargeting® Drive System K003776 2. Axon Instruments MP-1 Micropaositioner K99068 3. Radionics CRW-FMD Kgo2721 4. MSC pEEG uDrive Model 25/50 K991077 D. Description of Device The microTargeting® Drive Sys positioning of microelectrodes, stimulating electrodes, DBS ~ ele Date… | 1999 |
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 |
|---|---|---|---|
| K040979 | Elekta Microdrive, Model 916716 | 2004 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 4, 2024 | Class I | Z-0312-2025 | Process change control | A complaint was received (MDR 3002250546-2024-00003) prompting an investigation. The investigation revealed a schematic for a spacer tube which is too long relative to the size of other components was included in the build order for Lot… |
| May 10, 2018 | Class II | Z-2346-2018 | 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-2355-2018 | 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-2348-2018 | 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-2356-2018 | 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-2347-2018 | 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-2345-2018 | 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 14, 2005 | Not classified | Z-0895-05 | Other | Potential for non-sterile pin to contaminate sterile field |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 18.4 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K040979 (Elekta Instrument AB, 2004) has gone furthest, with 0 descendants of its own.
- 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 ricroTargeting® Drive System is intended-to be used with commetcially available stereotactic systerns for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, DBS™ electrodes of 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/K011775 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011775: Micro Targeting 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/K011775
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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