510(k) · Cleared
Recalled · 2010Microtargeting 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 Feb 23, 2001 after a 78-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 11 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it. It has been recalled 4 times.
- Decided
- Feb 23, 2001
- Review
- 78 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 4
- Predicates
- 0
10 later devices descend from it, 4 citing it directly. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- This deviceK003776 Microtargeting Drive SystemFHC, Inc. · 2001
- Descendant · cites it directly · 4 of its ownK092192 Waypoint Stereotactic SystemFHC, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK132611 Microtable SystemFred Haer Company, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK092562 Microtargeting Star Drive System, ComponentsFHC, Inc. · 2009 · Recalled
- Descendant · cites it directly · 1 of its ownK011775 Micro Targeting Drive SystemFHC, Inc. · 2001 · Recalled (Class I)
- Descendant · 3 generations on · 0 of its ownK233703 Bone Anchor (NGS-BA-01)ClearPoint Neuro, Inc. · 2024
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K011775 Micro Targeting Drive Systemcites it directly · 2001
Most influential descendants
Showing 5 of 10 · See all- K092192Waypoint Stereotactic SystemFHC, Inc. · 2010 · cites it directly4descendants
- K132611Microtable SystemFred Haer Company, Inc. · 2014 · 2 generations on1descendant
- K092562Microtargeting Star Drive System, ComponentsFHC, Inc. · 2009 · cites it directly1descendant
- K011775Micro Targeting Drive SystemFHC, Inc. · 2001 · cites it directly1descendant
- K233703Bone Anchor (NGS-BA-01)ClearPoint Neuro, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003776 | Microtargeting Drive System | FHC, Inc. | 2001 | — |
| +1 | K092192 | Waypoint Stereotactic System | FHC, Inc. | 2010 | — |
| +2 | K132611 | Microtable System | Fred Haer Company, Inc. | 2014 | — |
| +1 | K092562 | Microtargeting Star Drive System, Components | FHC, Inc. | 2009 | 9 |
| +1 | K011775 | Micro Targeting Drive System | FHC, Inc. | 2001 | Class I |
| +3 | K233703 | Bone Anchor (NGS-BA-01) | ClearPoint Neuro, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 1 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (10)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 30, 2010 | Not classified | Z-0313-2011 | Device Design | Fixation thumbscrew on the DBS depth stop adapter may be overtightened and damage the implantable lead. |
| Mar 30, 2010 | Not classified | Z-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-0311-2011 | Device Design | Fixation thumbscrew on the DBS depth stop adapter may be overtightened and damage the implantable lead. |
| Mar 14, 2005 | Not classified | Z-0895-05 | Other | Potential for non-sterile pin to contaminate sterile field |
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.
- K011775Micro Targeting Drive SystemFHC, Inc. · 2001 · Cites it directly · ◆ in the 2001 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K092192 (FHC, Inc., 2010) has gone furthest, with 4 descendants of its own.
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 | — |
https://510kreport.com/device/K003776 · printed Nov 4, 2026
Cite this page
510(k) Report. “K003776: Microtargeting Drive System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003776
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026