510(k) · Cleared
ClearedMammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer Stylet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Devicor Medical Products, Inc. · KNW Instrument, Biopsy
Cleared on Aug 8, 2016 as substantially equivalent to K112411 (Devicor Medical Products, Inc., 2012) after a 229-day review. Its family tree reaches back 4 generations to 2006. 2 later devices descend from it.
- Decided
- Aug 8, 2016
- Review
- 229 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K062832 (2006). 7 ancestors in all, the oldest K003297 (2001). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK062832 Vacora 14G Biopsy Probes, Models VB14116, VB14138C.R. Bard, Inc. · 2006 · Recalled
- 3 generations backK082681 Vacora Vacuum Assisted Biopsy SystemC.R. Bard, Inc. · 2008 · Recalled
- 2 generations backK093068 Finesse Ultra Breast Biospy System Driver - Blue, Pink, Probe…C.R. Bard, Inc. · 2009
- 1 generation backK112411 Mammotome Elite Biopsy SystemDevicor Medical Products, Inc. · 2012
- This deviceK153709 Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy…Devicor Medical Products, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK220595 NeoNavia Biopsy SystemNeodynamics AB · 2022
- Descendant · cites it directly · 0 of its ownK173316 SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU…Transmed7, LLC · 2018
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 |
|---|---|---|---|---|---|
| −4 | K062832 | Vacora 14G Biopsy Probes, Models VB14116, VB14138 | C.R. Bard, Inc. | 2006 | 1 |
| −3 | 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 | — |
| −1 | K112411 | Mammotome Elite Biopsy System | Devicor Medical Products, Inc. | 2012 | — |
| 0 (this device) | K153709 | Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G… | Devicor Medical Products, Inc. | 2016 | — |
| +1 | K220595 | NeoNavia Biopsy System | Neodynamics AB | 2022 | — |
| +1 | K173316 | SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft… | Transmed7, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K112411 | Mammotome Elite Biopsy SystemSummary page 4…Name: Mammotome® elite Biopsy System Device Classification Name: Instrument, Biopsy Premarket Notification # K112411 Manufacturer Devicor® Medical Products, Inc. Device The Mammotome elite® Biopsy Sy… | 2012 |
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?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K220595 (Neodynamics AB, 2022) has gone furthest, with 0 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. 2016, 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 Mammotome elite® Biopsy System is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis of breast abnormalities. • The Mammotome elite® Biopsy System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. • The Mammotome elite® Biopsy System is intended to provide breast tissue for histologic examination with partial removal of a palpable…
Read the full statement (219 words)
The Mammotome elite® Biopsy System is indicated to obtain tissue samples from the breast or axillary lymph nodes for
diagnostic analysis of breast abnormalities.
• The Mammotome elite® Biopsy System is intended to provide breast tissue for histologic examination with partial or
complete removal of the imaged abnormality.
• The Mammotome elite® Biopsy System is intended to provide breast tissue for histologic examination with partial
removal of a palpable abnormality.
The extent of a histologic abnormality cannot always be readily determined from the palpation or imaged appearance.
Therefore, the extent of removal of the palpated or 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.
In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or
radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the Mammotome elite® Biopsy System may also be used to
partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of the tissue is the
standard of care. 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/K153709 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153709: Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer Stylet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153709
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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