510(k) · Cleared
ClearedField-Lee Brain Biopsy Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American V. Mueller · HAO Instrument, Surgical, Non-Powered
Cleared on Sep 9, 1980 after a 43-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Sep 9, 1980
- Review
- 43 days
- Class
- Class I
- Product code
- HAO
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK801760 Field-Lee Brain Biopsy NeedleAmerican V. Mueller · 1980
- 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
- Descendant · cites it directly · 0 of its ownK974158 Orion Medical Inc. Disposable Brain Biopsy Needle for Sterotactic…Ortho Development Corp. · 1997
Most influential descendants
Showing 5 of 5 · 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
- K974158Orion Medical Inc. Disposable Brain Biopsy Needle for Sterotactic Guided BiopsyOrtho Development Corp. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K801760 | Field-Lee Brain Biopsy Needle | American V. Mueller | 1980 | — |
| +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 | — |
| +1 | K974158 | Orion Medical Inc. Disposable Brain Biopsy Needle for Sterotactic Guided Biopsy | Ortho Development Corp. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 HAO? 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 HAO device
- #1 K220920 Matreneu Percutaneous Balloon Compression Kitscore 4.0 · 1 generation · no Class I recall
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? (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, K060808 (PAJUNK GmbH Medizintechnologie, 2006) has gone furthest, with 3 descendants of its own.
How does its category compare?
All HAO devicesHAO Instrument, Surgical, Non-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HAO
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · HAO
Too few HAO 510(k)s in any year since 2007 to give a median.
Recalls per year · HAO
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HAO
8in 2025
MAUDE reports naming product code HAO, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 15 |
| 2010 | 0 | — | 1 | 30 |
| 2011 | 0 | — | 1 | 6 |
| 2012 | 0 | — | 0 | 15 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 12 |
| 2015 | 0 | — | 0 | 67 |
| 2016 | 0 | — | 0 | 55 |
| 2017 | 0 | — | 0 | 26 |
| 2018 | 0 | — | 0 | 10 |
| 2019 | 0 | — | 0 | 19 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 1 | — | 0 | 10 |
| 2023 | 0 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K801760 · printed Nov 4, 2026
Cite this page
510(k) Report. “K801760: Field-Lee Brain Biopsy Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K801760
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026