510(k) · Cleared
Recalled · Class II · 2026EnCor EnCompass™ Breast Biopsy and Tissue Removal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bard Peripheral Vascular, Inc. · KNW Instrument, Biopsy
Cleared on Dec 12, 2025 as substantially equivalent to K233220 (Senorx, Inc., 2023) after a 109-day review. Its family tree reaches back 5 generations to 1999. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 12, 2025
- Review
- 109 days
- Class
- Class II
- Product code
- KNW
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K991980 (1999). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK991980 Mammotome HH Hand-Held Probe, Vacuum Set, Control Module, HH…Ethicon Endo-Surgery, Inc. · 1999
- 4 generations backK030472 Mammotome Biopsy System Probe & Housing, Mammotome Hand-Held SystemEthicon Endo-Surgery, Inc. · 2003
- 3 generations backK093512 Encor Breast Biopsy SystemSenorx, Inc. · 2009
- 2 generations backK111100 Encor Enspire Breast Biopsy SystemC.R. Bard, Inc. · 2011
- 1 generation backK233220 EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast…Senorx, Inc. · 2023
- This deviceK252681 EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK262571 EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K991980 | Mammotome HH Hand-Held Probe, Vacuum Set, Control Module, HH Hand-Held Holster… | Ethicon Endo-Surgery, Inc. | 1999 | — |
| −4 | K030472 | Mammotome Biopsy System Probe & Housing, Mammotome Hand-Held System | Ethicon Endo-Surgery, Inc. | 2003 | — |
| −3 | K093512 | Encor Breast Biopsy System | Senorx, Inc. | 2009 | — |
| −2 | K111100 | Encor Enspire Breast Biopsy System | C.R. Bard, Inc. | 2011 | — |
| −1 | K233220 | EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver… | Senorx, Inc. | 2023 | — |
| 0 (this device) | K252681 | EnCor EnCompass™ Breast Biopsy and Tissue Removal System | Bard Peripheral Vascular, Inc. | 2025 | — |
| +1 | K262571 | EnCor EnCompass™ Breast Biopsy and Tissue Removal System | Bard Peripheral Vascular, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K233220 | EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver…Summary page 5…Classification Panel: General & Plastic Surgery Regulatory Class: II Regulation Number: 876.1075 Predicate Device: EnCor Enspire™ Breast Biopsy System (K233220, cleared on October 27, 2023) Reference Device: Brevera® Breast Biopsy System with Corlumina Imaging Technology (K163052)… | 2023 |
| † | K163052 | Brevera Biopsy System with Corlumina Imaging Technology | 2017 |
| † | K042290 | Vacuum Assisted Core Biopsy Device | 2004 |
| † | K250032 | Marquee™ Disposable Core Biopsy Instrument and Instrument Kit | 2025 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K262571 | EnCor EnCompass™ Breast Biopsy and Tissue Removal System | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 20, 2026 | Class II | Z-3275-2026 | Software design | Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH01-00020009) , 2) Pressure sensor (code E01-0054000E), which prompts the user to restart and… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K262571 (Bard Peripheral Vascular, Inc., 2026) 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. 2025, 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 EnCor EnCompass™ Breast Biopsy and Tissue Removal System is indicated to acquire breast tissue for histologic examination with partial or complete removal of the abnormality.
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/K252681 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252681: EnCor EnCompass™ Breast Biopsy and Tissue Removal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252681
Report an extraction error
Are you the manufacturer?
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