510(k) · Cleared
Recalled · 2008Vacora 14G Biopsy Probes, Models VB14116, VB14138
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 Oct 20, 2006 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it. It has been recalled once.
- Decided
- Oct 20, 2006
- Review
- 29 days
- Class
- Class II
- Product code
- KNW
- Recalls
- 1
- Predicates
- 0
9 later devices descend from it, 1 citing it directly.
- This deviceK062832 Vacora 14G Biopsy Probes, Models VB14116, VB14138C.R. Bard, Inc. · 2006
- Descendant · cites it directly · 8 of its ownK082681 Vacora Vacuum Assisted Biopsy SystemC.R. Bard, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 7 of its ownK093068 Finesse Ultra Breast Biospy System Driver - Blue, Pink, Probe…C.R. Bard, Inc. · 2009
- Descendant · 3 generations on · 3 of its ownK112411 Mammotome Elite Biopsy SystemDevicor Medical Products, Inc. · 2012
- Descendant · 4 generations on · 2 of its ownK153709 Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy…Devicor Medical Products, Inc. · 2016
- Descendant · 3 generations on · 2 of its ownK103359 Finesse Ultra Breast Biopsy System Driver (Blue, Pink)C.R. Bard, Inc. · 2010
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K082681Vacora Vacuum Assisted Biopsy SystemC.R. Bard, Inc. · 2008 · cites it directly8descendants
- K093068Finesse Ultra Breast Biospy System Driver - Blue, Pink, Probe FO1BLU, Foipnk, F14105USC.R. Bard, Inc. · 2009 · 2 generations on7descendants
- K112411Mammotome Elite Biopsy SystemDevicor Medical Products, Inc. · 2012 · 3 generations on3descendants
- K153709Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe…Devicor Medical Products, Inc. · 2016 · 4 generations on2descendants
- K103359Finesse Ultra Breast Biopsy System Driver (Blue, Pink)C.R. Bard, Inc. · 2010 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K062832 | Vacora 14G Biopsy Probes, Models VB14116, VB14138 | C.R. Bard, Inc. | 2006 | — |
| +1 | K082681 | Vacora Vacuum Assisted Biopsy System | C.R. Bard, Inc. | 2008 | 4 |
| +2 | K093068 | Finesse Ultra Breast Biospy System Driver - Blue, Pink, Probe FO1BLU, Foipnk… | C.R. Bard, Inc. | 2009 | — |
| +3 | K112411 | Mammotome Elite Biopsy System | Devicor Medical Products, Inc. | 2012 | — |
| +4 | K153709 | Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G… | Devicor Medical Products, Inc. | 2016 | — |
| +3 | K103359 | Finesse Ultra Breast Biopsy System Driver (Blue, Pink) | C.R. Bard, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082681 | Vacora Vacuum Assisted Biopsy System | 2008 | 8 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 12, 2008 | Not classified | Z-0183-2009 | Device Design | Some of the Vacora Biopsy Vacuum Assisted Biopsy Probe thumb wheels from these lots may fracture when fired using the prime/pierce option. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K082681 (C.R. Bard, Inc., 2008) has gone furthest, with 8 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) | — |
https://510kreport.com/device/K062832 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062832: Vacora 14G Biopsy Probes, Models VB14116, VB14138.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062832
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026