510(k) · Cleared
ClearedDaum Neurocut Neurobiopsyneedle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Daum Corp. · KNW Instrument, Biopsy
Cleared on Mar 30, 1999 after a 61-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Mar 30, 1999
- Review
- 61 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK990278 Daum Neurocut NeurobiopsyneedleDaum Corp. · 1999
- Descendant · cites it directly · 4 of its ownK032054 Radionics Nashold Biopsy Needle - Single UseRadionics, A Division of Tyco Healthcare Group LP · 2003
- Descendant · 2 generations on · 3 of its ownK060808 Brainpro, Brainpro AccessPAJUNK GmbH Medizintechnologie · 2006
- Descendant · 3 generations on · 1 of its ownK220897 Disposable Brain Biopsy Needle 2.0PAJUNK GmbH Medizintechnologie · 2022
- Descendant · 4 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 5 of 5 · 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 · 2 generations on3descendants
- K220897Disposable Brain Biopsy Needle 2.0PAJUNK GmbH Medizintechnologie · 2022 · 3 generations on1descendant
- K230201Disposable Pre-calibrated Brain Biopsy Needle 2.0PAJUNK GmbH Medizintechnologie · 2023 · 4 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) | K990278 | Daum Neurocut Neurobiopsyneedle | Daum Corp. | 1999 | — |
| +1 | K032054 | Radionics Nashold Biopsy Needle - Single Use | Radionics, A Division of Tyco Healthcare Group LP | 2003 | — |
| +2 | K060808 | Brainpro, Brainpro Access | PAJUNK GmbH Medizintechnologie | 2006 | — |
| +3 | K220897 | Disposable Brain Biopsy Needle 2.0 | PAJUNK GmbH Medizintechnologie | 2022 | — |
| +4 | 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 |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KNW? 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 KNW device
- #1 K260572 Marrow Marxmanscore 14.5 · 10 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
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?
- 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 KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNW
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNW
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNW
1in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · KNW
1,667in 2025
MAUDE reports naming product code KNW, 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 | 6 | 94 | 1 | 766 |
| 2008 | 4 | 53 | 7 | 363 |
| 2009 | 6 | 35 | 3 | 351 |
| 2010 | 3 | 57 | 2 | 162 |
| 2011 | 10 | 64 | 5 | 67 |
| 2012 | 7 | 94 | 1 | 93 |
| 2013 | 3 | 100 | 1 (1) | 98 |
| 2014 | 8 | 95 | 3 | 193 |
| 2015 | 10 | 106 | 0 | 591 |
| 2016 | 9 | 127 | 5 | 297 |
| 2017 | 8 | 90 | 1 | 760 |
| 2018 | 7 | 71 | 0 | 1,012 |
| 2019 | 5 | 94 | 4 | 4,195 |
| 2020 | 8 | 92 | 0 | 5,120 |
| 2021 | 9 | 54 | 3 | 1,020 |
| 2022 | 8 | 203 | 3 | 535 |
| 2023 | 7 | 164 | 2 | 931 |
| 2024 | 5 | 114 | 1 | 1,283 |
| 2025 | 12 | 178 | 0 | 1,667 |
| 2026 | 7 | 29 | 4 (3) | — |
What is it indicated for?
The Daum NeuroCut NeuroBiopsyNeedle is designed for b:opsy of the soft tissue in the brain.
The patented surface treatment of the needle optimizes its use in the MRI setting, producing a low-artifact visualization of the needle.
Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990278 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990278: Daum Neurocut Neurobiopsyneedle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990278
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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