510(k) · Cleared
ClearedAD-Tech's Brain Biopsy Needle for Stereotaxic
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ad-Tech Medical Instrument Corp · HAW Neurological Stereotaxic Instrument
Cleared on Nov 23, 1992 after an 88-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Nov 23, 1992
- Review
- 88 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 4 citing it directly.
- This deviceK924348 AD-Tech's Brain Biopsy Needle for StereotaxicAd-Tech Medical Instrument Corp · 1992
- Descendant · cites it directly · 4 of its ownK032054 Radionics Nashold Biopsy Needle - Single UseRadionics, A Division of Tyco Healthcare Group LP · 2003
- Descendant · cites it directly · 3 of its ownK060808 Brainpro, Brainpro AccessPAJUNK GmbH Medizintechnologie · 2006
- Descendant · 2 generations on · 1 of its ownK220897 Disposable Brain Biopsy Needle 2.0PAJUNK GmbH Medizintechnologie · 2022
- Descendant · 3 generations on · 0 of its ownK230201 Disposable Pre-calibrated Brain Biopsy Needle 2.0PAJUNK GmbH Medizintechnologie · 2023
- Descendant · cites it directly · 0 of its ownK112094 Brain Biopsy NeedleAd-Tech Medical Instrument Corp · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K032054Radionics Nashold Biopsy Needle - Single UseRadionics, A Division of Tyco Healthcare Group LP · 2003 · cites it directly4descendants
- K060808Brainpro, Brainpro AccessPAJUNK GmbH Medizintechnologie · 2006 · cites it directly3descendants
- K220897Disposable Brain Biopsy Needle 2.0PAJUNK GmbH Medizintechnologie · 2022 · 2 generations on1descendant
- K230201Disposable Pre-calibrated Brain Biopsy Needle 2.0PAJUNK GmbH Medizintechnologie · 2023 · 3 generations on0descendants
- K112094Brain Biopsy NeedleAd-Tech Medical Instrument Corp · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K924348 | AD-Tech's Brain Biopsy Needle for Stereotaxic | Ad-Tech Medical Instrument Corp | 1992 | — |
| +1 | K032054 | Radionics Nashold Biopsy Needle - Single Use | Radionics, A Division of Tyco Healthcare Group LP | 2003 | — |
| +1 | K060808 | Brainpro, Brainpro Access | PAJUNK GmbH Medizintechnologie | 2006 | — |
| +2 | K220897 | Disposable Brain Biopsy Needle 2.0 | PAJUNK GmbH Medizintechnologie | 2022 | — |
| +3 | K230201 | Disposable Pre-calibrated Brain Biopsy Needle 2.0 | PAJUNK GmbH Medizintechnologie | 2023 | — |
| +1 | K112094 | Brain Biopsy Needle | Ad-Tech Medical Instrument Corp | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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.
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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K032054 (Radionics, A Division of Tyco Healthcare Group LP, 2003) 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/K924348 · printed Nov 5, 2026
Cite this page
510(k) Report. “K924348: AD-Tech's Brain Biopsy Needle for Stereotaxic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K924348
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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