510(k) · Cleared
ClearedMammotome HH Hand-Held Probe, Vacuum Set, Control Module, HH Hand-Held Holster and Cables, Software Package, Footswitch,
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethicon Endo-Surgery, Inc. · KNW Instrument, Biopsy
Cleared on Aug 17, 1999 after a 64-day review. The FDA summary names its predicate without a number. 22 later devices descend from it.
- Decided
- Aug 17, 1999
- Review
- 64 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 0
22 later devices descend from it, 6 citing it directly.
- This deviceK991980 Mammotome HH Hand-Held Probe, Vacuum Set, Control Module, HH…Ethicon Endo-Surgery, Inc. · 1999
- Descendant · cites it directly · 7 of its ownK030472 Mammotome Biopsy System Probe & Housing, Mammotome Hand-Held SystemEthicon Endo-Surgery, Inc. · 2003
- Descendant · 2 generations on · 5 of its ownK093512 Encor Breast Biopsy SystemSenorx, Inc. · 2009
- Descendant · cites it directly · 5 of its ownK020047 Rubicor Breast Biopsy DeviceRubicor Medical, Inc. · 2002 · Recalled
- Descendant · cites it directly · 4 of its ownK024089 Vacuflash Biopsy SystemBip USA, Inc. · 2003
- Descendant · 2 generations on · 4 of its ownK023601 Rubicor Encapsule Breast Biopsy Device, Model 30086Rubicor Medical, Inc. · 2002 · Recalled
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K030472Mammotome Biopsy System Probe & Housing, Mammotome Hand-Held SystemEthicon Endo-Surgery, Inc. · 2003 · cites it directly7descendants
- K093512Encor Breast Biopsy SystemSenorx, Inc. · 2009 · 2 generations on5descendants
- K020047Rubicor Breast Biopsy DeviceRubicor Medical, Inc. · 2002 · cites it directly5descendants
- K024089Vacuflash Biopsy SystemBip USA, Inc. · 2003 · cites it directly4descendants
- K023601Rubicor Encapsule Breast Biopsy Device, Model 30086Rubicor Medical, Inc. · 2002 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991980 | Mammotome HH Hand-Held Probe, Vacuum Set, Control Module, HH Hand-Held Holster… | Ethicon Endo-Surgery, Inc. | 1999 | — |
| +1 | K030472 | Mammotome Biopsy System Probe & Housing, Mammotome Hand-Held System | Ethicon Endo-Surgery, Inc. | 2003 | — |
| +2 | K093512 | Encor Breast Biopsy System | Senorx, Inc. | 2009 | — |
| +1 | K020047 | Rubicor Breast Biopsy Device | Rubicor Medical, Inc. | 2002 | 1 |
| +1 | K024089 | Vacuflash Biopsy System | Bip USA, Inc. | 2003 | — |
| +2 | K023601 | Rubicor Encapsule Breast Biopsy Device, Model 30086 | Rubicor Medical, Inc. | 2002 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 4 | 0 |
| 2003 | 5 | 0 |
| 2005 | 3 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (4)
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 |
|---|---|---|---|
| * | — | Mammotome® Biopsy Multi-Probe and Housing Named without a submission number | |
| * | — | Powered Suction Pump Named without a submission number | |
| * | — | Tubing Clamp and Tubing Accessory Named without a submission number | |
| * | — | Arm Clamp Named without a submission number |
What descends from it? (22)
See all 226 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030472 | Mammotome Biopsy System Probe & Housing, Mammotome Hand-Held System | 2003 | 7 |
| K020047 | Rubicor Breast Biopsy Device | 2002 | 5 |
| K024089 | Vacuflash Biopsy System | 2003 | 4 |
| K053151 | Rubicor Magic Breast Biopsy Device | 2005 | 3 |
| K013641 | Senorx Biopsy Device, Driver, Control Module, Including Accessories (Power… | 2002 | 1 |
| K032847 | Excisor Bioptome, Model 01-0004 | 2003 | 0 |
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?
- Of its descendants, K030472 (Ethicon Endo-Surgery, Inc., 2003) 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.
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® Hand-Held System is indicated for use for incisional breast biopsy including microcalcifications, masses, spiculated masses, asymmetric densities, multi-focal disease, and diffused tissue.
The Mammotome® Hand-Held System is for diagnostic use only and is not indicated for therapeutic use.
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/K991980 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991980: Mammotome HH Hand-Held Probe, Vacuum Set, Control Module, HH Hand-Held Holster and Cables, Software Package, Footswitch,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991980
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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