510(k) · Cleared
Recalled · 2010Vacuum Assisted Core Biopsy Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suros Surgical Systems, Inc. · KNW Instrument, Biopsy
Cleared on Oct 6, 2004 after a 43-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it. It has been recalled 4 times.
- Decided
- Oct 6, 2004
- Review
- 43 days
- Class
- Class II
- Product code
- KNW
- Recalls
- 4
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK042290 Vacuum Assisted Core Biopsy DeviceSuros Surgical Systems, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK163052 Brevera Biopsy System with Corlumina Imaging TechnologyHologic, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 0 of its ownK262792 Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)Hologic, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK180233 Eviva Stereotactic Guided Breast Biopsy SystemHologic, Inc. · 2018
Most influential descendants
Showing 3 of 3 · See all- K163052Brevera Biopsy System with Corlumina Imaging TechnologyHologic, Inc. · 2017 · cites it directly1descendant
- K262792Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)Hologic, Inc. · 2026 · 2 generations on0descendants
- K180233Eviva Stereotactic Guided Breast Biopsy SystemHologic, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042290 | Vacuum Assisted Core Biopsy Device | Suros Surgical Systems, Inc. | 2004 | — |
| +1 | K163052 | Brevera Biopsy System with Corlumina Imaging Technology | Hologic, Inc. | 2017 | 1 |
| +2 | K262792 | Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) | Hologic, Inc. | 2026 | — |
| +1 | K180233 | Eviva Stereotactic Guided Breast Biopsy System | Hologic, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 11, 2010 | Not classified | Z-2285-2010 | Packaging | The firm received a customer complaint that the a device labeled as ATEC 0912-12 was actually ATEC 0912-20. |
| Feb 1, 2010 | Not classified | Z-1160-2010 | Employee error | The product is labeled as ATEC0909-12 but it actually contains 0909-20. |
| Sep 22, 2008 | Not classified | Z-0275-2009 | Process control | The distal tip of the needle may become detached and remain in the patient, requiring surgical removal. |
| Dec 15, 2006 | Not classified | Z-0362-2007 | Other | The handpiece package may have an incorrect part number on the inner package. Error could result in over-penetration of the biopsy needle. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K163052 (Hologic, Inc., 2017) has gone furthest, with 1 descendant 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 ATEC® Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. The ATEC® Breast Biopsy System 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 manmographic appearance. Therefore, the extent of removal of the imaged evidence of an abnorninality…
Read the full statement (99 words)
The ATEC® Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. The ATEC® Breast Biopsy System 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 manmographic appearance. Therefore, the extent of removal of the imaged evidence of an abnorninality does not predict theextent of removal ofhistologic abnormality, e.g., malignancy. Wh'/en the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedure.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K042290 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042290: Vacuum Assisted Core Biopsy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042290
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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