510(k) · Cleared
ClearedBard Biopty-Cut Biopsy Needle/with Spacer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · KNW Instrument, Biopsy
Cleared on Jul 30, 1996 as substantially equivalent to K871390 (C.R. Bard, Inc., 1987) and 1 other predicate after a 63-day review. Its family tree reaches back 1 generation to 1987. 2 later devices descend from it.
- Decided
- Jul 30, 1996
- Review
- 63 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K871390 (1987). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK871390 Bard Biopty Biopsy SystemC.R. Bard, Inc. · 1987
- This deviceK962077 Bard Biopty-Cut Biopsy Needle/with SpacerC.R. Bard, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK191315 Remington Medical, Inc. Automatic Cutting Needle (NAC)Remington Medical, Inc. · 2019 · Recalled
- Descendant · cites it directly · 0 of its ownK110112 Cell-Tissue Converter (CTC) Syringe with NeedleRongshan LI · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K871390 | Bard Biopty Biopsy System | C.R. Bard, Inc. | 1987 | — |
| 0 (this device) | K962077 | Bard Biopty-Cut Biopsy Needle/with Spacer | C.R. Bard, Inc. | 1996 | — |
| +1 | K191315 | Remington Medical, Inc. Automatic Cutting Needle (NAC) | Remington Medical, Inc. | 2019 | 1 |
| +1 | K110112 | Cell-Tissue Converter (CTC) Syringe with Needle | Rongshan LI | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K871390 | Bard Biopty Biopsy SystemSummary page 3…Characteristic CURRENT PROPOSED Bard® Biopty-Cut® Biopsy Bard® Biopty-Cut® Needle Bard® Biopty-Cut® Needle Needle with and without Spacer with and without Spacer 510(k) #K871390 510(k) #K910720 Available Needle Diameters 14,18, 20 gauge 12,14,16,18,20 gauge Sample Notch Length 17mm for 18 gauge Centimet… | 1987 |
| * | K910720 | Bard Biopty-Cut Biopsy Needle with SpacerSummary page 3…URRENT PROPOSED Bard® Biopty-Cut® Biopsy Bard® Biopty-Cut® Needle Bard® Biopty-Cut® Needle Needle with and without Spacer with and without Spacer 510(k) #K871390 510(k) #K910720 Available Needle Diameters 14,18, 20 gauge 12,14,16,18,20 gauge Sample Notch Length 17mm for 18 gauge Centimeter Gradations No… | 1991 |
What descends from it? (2)
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?
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 device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
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/K962077 · printed Nov 5, 2026
Cite this page
510(k) Report. “K962077: Bard Biopty-Cut Biopsy Needle/with Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962077
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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