510(k) · Cleared
ClearedEnCor 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 Aug 14, 2026 as substantially equivalent to K252681 (Bard Peripheral Vascular, Inc., 2025) after a 21-day review. Its family tree reaches back 6 generations to 1999.
- Decided
- Aug 14, 2026
- Review
- 21 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K991980 (1999). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK991980 Mammotome HH Hand-Held Probe, Vacuum Set, Control Module, HH…Ethicon Endo-Surgery, Inc. · 1999
- 5 generations backK030472 Mammotome Biopsy System Probe & Housing, Mammotome Hand-Held SystemEthicon Endo-Surgery, Inc. · 2003
- 4 generations backK093512 Encor Breast Biopsy SystemSenorx, Inc. · 2009
- 3 generations backK111100 Encor Enspire Breast Biopsy SystemC.R. Bard, Inc. · 2011
- 2 generations backK233220 EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast…Senorx, Inc. · 2023
- 1 generation backK252681 EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc. · 2025 · Recalled
- This deviceK262571 EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K991980 | Mammotome HH Hand-Held Probe, Vacuum Set, Control Module, HH Hand-Held Holster… | Ethicon Endo-Surgery, Inc. | 1999 | — |
| −5 | K030472 | Mammotome Biopsy System Probe & Housing, Mammotome Hand-Held System | Ethicon Endo-Surgery, Inc. | 2003 | — |
| −4 | K093512 | Encor Breast Biopsy System | Senorx, Inc. | 2009 | — |
| −3 | K111100 | Encor Enspire Breast Biopsy System | C.R. Bard, Inc. | 2011 | — |
| −2 | K233220 | EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver… | Senorx, Inc. | 2023 | — |
| −1 | K252681 | EnCor EnCompass™ Breast Biopsy and Tissue Removal System | Bard Peripheral Vascular, Inc. | 2025 | 1 |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K252681 | EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemSummary page 5…Regulatory Class: II Regulation Number: 876.1075 Predicate Device: EnCor EnCompass™ Breast Biopsy and Tissue Removal System (K252681, cleared on December 12th, 2025) Device Description: The subject device, the EnCor EnCompass™ Breast Biop… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- 3 of the 10 ancestors have a recall of any class.
How does its category compare?
All KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 as stated in the FDA summary.
https://510kreport.com/device/K262571 · printed Nov 5, 2026
Cite this page
510(k) Report. “K262571: 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 5, 2026. https://510kreport.com/device/K262571
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026