510(k) · Cleared
ClearedRadionics Nashold Biopsy Needle - Single Use
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radionics, A Division of Tyco Healthcare Group LP · HAW Neurological Stereotaxic Instrument
Cleared on Sep 15, 2003 as substantially equivalent to K990278 (Daum Corp., 1999) and 1 other predicate after a 75-day review. Its family tree reaches back 1 generation to 1992. 4 later devices descend from it.
- Decided
- Sep 15, 2003
- Review
- 75 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K924348 (1992). 2 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK924348 AD-Tech's Brain Biopsy Needle for StereotaxicAd-Tech Medical Instrument Corp · 1992
- This deviceK032054 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 · 2 generations on · 0 of its ownK112094 Brain Biopsy NeedleAd-Tech Medical Instrument Corp · 2012
Most influential descendants
Showing 4 of 4 · See all- 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 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924348 | AD-Tech's Brain Biopsy Needle for Stereotaxic | Ad-Tech Medical Instrument Corp | 1992 | — |
| 0 (this device) | 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 | — |
| +2 | K112094 | Brain Biopsy Needle | Ad-Tech Medical Instrument Corp | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K990278 | Daum Neurocut NeurobiopsyneedleSummary page 1…N CODE: 21 C.F.R. 6 882.4560 PREDICATE DEVICES: MRI Devices Corporation (DAUM CORP.) Daum Neurocut Neurobiopsy Needle, K990278 Ad-Tech’s Brain Biopsy Needle For Stereotaxic, K924348 Elekta Instrum… | 1999 |
| * | K924348 | AD-Tech's Brain Biopsy Needle for StereotaxicSummary page 1…oration (DAUM CORP.) Daum Neurocut Neurobiopsy Needle, K990278 Ad-Tech’s Brain Biopsy Needle For Stereotaxic, K924348 Elekta Instrument’s Leksell Sedan Biopsy Needle, 5 1O(k) unk INTENDED USE: The Ra… | 1992 |
| * | — | Elekta Instrument’s Leksell Sedan Biopsy Needle Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060808 | Brainpro, Brainpro Access | 2006 | 3 |
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?
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 Radionics Nashold Biopsy Needle is intended for single patient use in stereotactic biopsy of brain tumors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032054 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032054: Radionics Nashold Biopsy Needle - Single Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032054
Report an extraction error
Are you the manufacturer?
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