510(k) · Cleared
ClearedOrion Medical Inc. Disposable Brain Biopsy Needle for Sterotactic Guided Biopsy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Development Corp. · KNW Instrument, Biopsy
Cleared on Dec 9, 1997 as substantially equivalent to K924348 (Ad-Tech Medical Instrument Corp, 1992) and 1 other predicate after a 36-day review. Its family tree reaches back 1 generation to 1980.
- Decided
- Dec 9, 1997
- Review
- 36 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K801760 (1980). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK801760 Field-Lee Brain Biopsy NeedleAmerican V. Mueller · 1980
- This deviceK974158 Orion Medical Inc. Disposable Brain Biopsy Needle for Sterotactic…Ortho Development Corp. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K801760 | Field-Lee Brain Biopsy Needle | American V. Mueller | 1980 | — |
| 0 (this device) | K974158 | Orion Medical Inc. Disposable Brain Biopsy Needle for Sterotactic Guided Biopsy | Ortho Development Corp. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 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 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? (2)
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 |
|---|---|---|---|
| * | K924348 | AD-Tech's Brain Biopsy Needle for StereotaxicSummary page 1…needles are 21cm from the hub of the needle to the sharp front cutting edge. Equivalen Devices: Ad-Tech's Brain Biopsy Needle (Ad-Tech Medical Instrument Corporation) K924348 Field-Lee Brain Biopsy Needle (V. Mueller) K801760 NBN Brain Biopsy Needie (Radionics, Inc.) BioTac Brain Biopsy Needle (Progres… | 1992 |
| * | K801760 | Field-Lee Brain Biopsy NeedleSummary page 1…sharp front cutting edge. Equivalen Devices: Ad-Tech's Brain Biopsy Needle (Ad-Tech Medical Instrument Corporation) K924348 Field-Lee Brain Biopsy Needle (V. Mueller) K801760 NBN Brain Biopsy Needie (Radionics, Inc.) BioTac Brain Biopsy Needle (Progress Mankind Technology) Summary Statement: The Orion… | 1980 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
- 3 other devices also cite its predicate K924348.
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 Orion Medical Disposable Brain Biopsy Needle is an aspiration biopsy needle to remove and sample tissue within the brain in conjunction with a sterotactic head frame. The following statement describes the indications for use of Orion Medical's 14 gauge, 16 gauge, and 18 gauge sterotactic disposable brain biopsy needle: Sterotactic biopsy needle used to sample brain tissue or to extract brain tissue samples to determine tissue abnormmality or any…
Read the full statement (149 words)
The Orion Medical Disposable Brain Biopsy Needle is an aspiration biopsy needle to remove and sample tissue within the brain in conjunction with a sterotactic head frame. The following statement describes the indications for use of Orion Medical's 14 gauge, 16 gauge, and 18 gauge sterotactic disposable brain biopsy needle:
Sterotactic biopsy needle used to sample brain tissue or to extract brain tissue samples to determine tissue abnormmality or any deviation from healthy brain tissue.
Tissue samples are extracted via the cannula using a syringe to aspirate. The cannula is then removed and the tissue sample is placed on a glass slide or sample dish, which is sent to anatomical pathology for smear analysis to determine tissue type.
Needile to be used in conjunction with a sterotactic frame with a center-of-the-arc of 21cm. The needles are 21cm from the hub of the needle to the sharp front cutting edge.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974158 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974158: Orion Medical Inc. Disposable Brain Biopsy Needle for Sterotactic Guided Biopsy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974158
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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