510(k) · Cleared
ClearedBrainpro, Brainpro Access
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
PAJUNK GmbH Medizintechnologie · HAW Neurological Stereotaxic Instrument
Cleared on Jul 25, 2006 as substantially equivalent to K032054 (Radionics, A Division of Tyco Healthcare Group LP, 2003) and 2 other predicates after a 123-day review. Its family tree reaches back 2 generations to 1992. 3 later devices descend from it.
- Decided
- Jul 25, 2006
- Review
- 123 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K924348 (1992). 4 ancestors in all, the oldest K801760 (1980). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK924348 AD-Tech's Brain Biopsy Needle for StereotaxicAd-Tech Medical Instrument Corp · 1992
- 1 generation backK032054 Radionics Nashold Biopsy Needle - Single UseRadionics, A Division of Tyco Healthcare Group LP · 2003
- This deviceK060808 Brainpro, Brainpro AccessPAJUNK GmbH Medizintechnologie · 2006
- Descendant · cites it directly · 1 of its ownK220897 Disposable Brain Biopsy Needle 2.0PAJUNK GmbH Medizintechnologie · 2022
- Descendant · 2 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
Most influential descendants
Showing 3 of 3 · See all- K220897Disposable Brain Biopsy Needle 2.0PAJUNK GmbH Medizintechnologie · 2022 · cites it directly1descendant
- K230201Disposable Pre-calibrated Brain Biopsy Needle 2.0PAJUNK GmbH Medizintechnologie · 2023 · 2 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 |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K060808 | Brainpro, Brainpro Access | PAJUNK GmbH Medizintechnologie | 2006 | — |
| +1 | K220897 | Disposable Brain Biopsy Needle 2.0 | PAJUNK GmbH Medizintechnologie | 2022 | — |
| +2 | K230201 | Disposable Pre-calibrated Brain Biopsy Needle 2.0 | PAJUNK GmbH Medizintechnologie | 2023 | — |
| +1 | K112094 | Brain Biopsy Needle | Ad-Tech Medical Instrument Corp | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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? (3)
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 |
|---|---|---|---|
| * | K032054 | Radionics Nashold Biopsy Needle - Single UseSummary page 1…tion:ReuaoyCssI Proposed Product HAW Classification Code. Panel: Neurology Predicate Devices: 1. Radionics Nashold Biopsy needle - Single use K032054 2. Ad-Tech Medical Instrument Corporation K924348 3. Field Lee Brain Biopsy n… | 2003 |
| * | K924348 | AD-Tech's Brain Biopsy Needle for StereotaxicSummary page 1…Panel: Neurology Predicate Devices: 1. Radionics Nashold Biopsy needle - Single use K032054 2. Ad-Tech Medical Instrument Corporation K924348 3. Field Lee Brain Biopsy needle K801760 PMN Co PMN-BrainPro-CORRAdOC… | 1992 |
| * | K801760 | Field-Lee Brain Biopsy NeedleSummary page 1…Biopsy needle - Single use K032054 2. Ad-Tech Medical Instrument Corporation K924348 3. Field Lee Brain Biopsy needle K801760 PMN Co PMN-BrainPro-CORRAdOC CQ 07-2006 - 5- BrainPro and… | 1980 |
| † | K020631 | IPLAN | 2002 |
What descends from it? (3)
2 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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 10.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K220897 (PAJUNK GmbH Medizintechnologie, 2022) has gone furthest, with 1 descendant 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 | — |
What is it indicated for?
The Pajunk BrainPro biopsy cannula for brain biopsy is a single-use device intended for use in stereotactic and other guided biopsy of brain tissue, for example brain tumors. The BrainPro is provided in a set. The Pajunk BrainPro Biopsy Needle is a dual cannula device made from stainless steel or titanium. The cannula requires vacuum suction provided by a syringe to draw the tissue into the needle. The inner cannula is then rotated against the outer…
Read the full statement (118 words)
The Pajunk BrainPro biopsy cannula for brain biopsy is a single-use device intended for use in stereotactic and other guided biopsy of brain tissue, for example brain tumors. The BrainPro is provided in a set.
The Pajunk BrainPro Biopsy Needle is a dual cannula device made from stainless steel or titanium. The cannula requires vacuum suction provided by a syringe to draw the tissue into the needle. The inner cannula is then rotated against the outer cannula to cut the tissue.
The Pajunk BrainPro Access is an optional single-use anchoring and guidance instrument for Pajunks BrainPro biopsy cannula with cutting titanium thread for drill holes. It is used in brain biopsy procedures. The BrainPro Access is provided sterile.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060808 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060808: Brainpro, Brainpro Access.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060808
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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