510(k) · Cleared
Recalled · 2009Vacora Vacuum Assisted Biopsy System
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 15, 2008 as substantially equivalent to K062832 (C.R. Bard, Inc., 2006) after a 30-day review. Its family tree reaches back 1 generation to 2006. 8 later devices descend from it. It has been recalled 4 times.
- Decided
- Oct 15, 2008
- Review
- 30 days
- Class
- Class II
- Product code
- KNW
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 1 generation to K062832 (2006). 8 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK062832 Vacora 14G Biopsy Probes, Models VB14116, VB14138C.R. Bard, Inc. · 2006 · Recalled
- This deviceK082681 Vacora Vacuum Assisted Biopsy SystemC.R. Bard, Inc. · 2008
- Descendant · cites it directly · 7 of its ownK093068 Finesse Ultra Breast Biospy System Driver - Blue, Pink, Probe…C.R. Bard, Inc. · 2009
- Descendant · 2 generations on · 3 of its ownK112411 Mammotome Elite Biopsy SystemDevicor Medical Products, Inc. · 2012
- Descendant · 3 generations on · 2 of its ownK153709 Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy…Devicor Medical Products, Inc. · 2016
- Descendant · 2 generations on · 2 of its ownK103359 Finesse Ultra Breast Biopsy System Driver (Blue, Pink)C.R. Bard, Inc. · 2010
- Descendant · 3 generations on · 1 of its ownK192948 EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G…Bard Peripheral Vascular, Inc. · 2019
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K093068Finesse Ultra Breast Biospy System Driver - Blue, Pink, Probe FO1BLU, Foipnk, F14105USC.R. Bard, Inc. · 2009 · cites it directly7descendants
- K112411Mammotome Elite Biopsy SystemDevicor Medical Products, Inc. · 2012 · 2 generations on3descendants
- K153709Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe…Devicor Medical Products, Inc. · 2016 · 3 generations on2descendants
- K103359Finesse Ultra Breast Biopsy System Driver (Blue, Pink)C.R. Bard, Inc. · 2010 · 2 generations on2descendants
- K192948EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast…Bard Peripheral Vascular, Inc. · 2019 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K062832 | Vacora 14G Biopsy Probes, Models VB14116, VB14138 | C.R. Bard, Inc. | 2006 | 1 |
| 0 (this device) | K082681 | Vacora Vacuum Assisted Biopsy System | C.R. Bard, Inc. | 2008 | — |
| +1 | K093068 | Finesse Ultra Breast Biospy System Driver - Blue, Pink, Probe FO1BLU, Foipnk… | C.R. Bard, Inc. | 2009 | — |
| +2 | K112411 | Mammotome Elite Biopsy System | Devicor Medical Products, Inc. | 2012 | — |
| +3 | K153709 | Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G… | Devicor Medical Products, Inc. | 2016 | — |
| +2 | K103359 | Finesse Ultra Breast Biopsy System Driver (Blue, Pink) | C.R. Bard, Inc. | 2010 | — |
| +3 | K192948 | EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation… | Bard Peripheral Vascular, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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? (1)
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 |
|---|---|---|---|
| * | K062832 | Vacora 14G Biopsy Probes, Models VB14116, VB14138Summary page 1…lassification: Class 11 Classification Panel: Gastroenterology/Urology 3. Predicate Device: Bard® Vacora® Vacuum Assisted Biopsy System (K0062832, clearance date October 20, 2006) 4. Summary of Change: The modification from the predicate to the subject Vacora®D Vacuum Assi… | 2006 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093068 | Finesse Ultra Breast Biospy System Driver - Blue, Pink, Probe FO1BLU, Foipnk, F14105US | 2009 | 7 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 26, 2009 | Not classified | Z-1881-2009 | Process control | Some Vacora 10G Plastic Coaxial Cannulas may leave a small metal filament in the breast or the sample obtained post procedure. |
| Mar 26, 2009 | Not classified | Z-1879-2009 | Process control | Some Vacora 10G Plastic Coaxial Cannulas may leave a small metal filament in the breast or the sample obtained post procedure. |
| Mar 26, 2009 | Not classified | Z-1880-2009 | Process control | Some Vacora 10G Plastic Coaxial Cannulas may leave a small metal filament in the breast or the sample obtained post procedure. |
| Mar 26, 2009 | Not classified | Z-1882-2009 | Process control | Some Vacora 10G Plastic Coaxial Cannulas may leave a small metal filament in the breast or the sample obtained post procedure. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K093068 (C.R. Bard, Inc., 2009) has gone furthest, with 7 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. 2008, this device’s year, is highlighted.
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 Vacora® Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. The instrument is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082681 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082681: Vacora Vacuum Assisted Biopsy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082681
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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