510(k) · Cleared
ClearedFinesse Ultra Breast Biopsy System Driver (Blue, Pink)
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 Dec 27, 2010 as substantially equivalent to K093068 (C.R. Bard, Inc., 2009) after a 41-day review. Its family tree reaches back 3 generations to 2006. 2 later devices descend from it.
- Decided
- Dec 27, 2010
- Review
- 41 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K062832 (2006). 5 ancestors in all, the oldest K003297 (2001). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK062832 Vacora 14G Biopsy Probes, Models VB14116, VB14138C.R. Bard, Inc. · 2006 · Recalled
- 2 generations backK082681 Vacora Vacuum Assisted Biopsy SystemC.R. Bard, Inc. · 2008 · Recalled
- 1 generation backK093068 Finesse Ultra Breast Biospy System Driver - Blue, Pink, Probe…C.R. Bard, Inc. · 2009
- This deviceK103359 Finesse Ultra Breast Biopsy System Driver (Blue, Pink)C.R. Bard, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK192948 EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G…Bard Peripheral Vascular, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK211933 EleVation Breast Biopsy SystemBard Peripheral Vascular · 2021
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 |
|---|---|---|---|---|---|
| −3 | K062832 | Vacora 14G Biopsy Probes, Models VB14116, VB14138 | C.R. Bard, Inc. | 2006 | 1 |
| −2 | K082681 | Vacora Vacuum Assisted Biopsy System | C.R. Bard, Inc. | 2008 | 4 |
| −1 | K093068 | Finesse Ultra Breast Biospy System Driver - Blue, Pink, Probe FO1BLU, Foipnk… | C.R. Bard, Inc. | 2009 | — |
| 0 (this device) | K103359 | Finesse Ultra Breast Biopsy System Driver (Blue, Pink) | C.R. Bard, Inc. | 2010 | — |
| +1 | K192948 | EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation… | Bard Peripheral Vascular, Inc. | 2019 | — |
| +2 | K211933 | EleVation Breast Biopsy System | Bard Peripheral Vascular | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K093068 | Finesse Ultra Breast Biospy System Driver - Blue, Pink, Probe FO1BLU, Foipnk, F14105USSummary page 1…Classification: Class 11 Classification Panel: Gastroenterology/Urology Predicate Device: *FINESSE T M Ultra Breast Biopsy System (K093068, cleared November 10, 2009), manufactured by Bard Peripheral Vascular, Inc. Bard Peripheral Vascular, Inc.… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192948 | EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast… | 2019 | 1 |
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?
- The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 1.1 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K192948 (Bard Peripheral Vascular, Inc., 2019) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K093068.
How does its category compare?
All KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 FINESSE™ Ultra Breast Biopsy System Driver is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis 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…
Read the full statement (109 words)
The FINESSE™ Ultra Breast Biopsy System Driver is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis 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/K103359 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103359: Finesse Ultra Breast Biopsy System Driver (Blue, Pink).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103359
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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