510(k) · Cleared
Recalled · Class II · 2025Brevera Biopsy System with Corlumina Imaging Technology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · KNW Instrument, Biopsy
Cleared on Mar 29, 2017 as substantially equivalent to K042290 (Suros Surgical Systems, Inc., 2004) and 1 other predicate after a 148-day review. Its family tree reaches back 5 generations to 2002. 1 later device descends from it. It has been recalled once.
- Decided
- Mar 29, 2017
- Review
- 148 days
- Class
- Class II
- Product code
- KNW
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K021113 (2002). 8 ancestors in all, the oldest K953404 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK021113 MammopathFischer Imaging Corp. · 2002
- 4 generations backK052433 Pixarray 100 Digital Specimen Radiography (DSR) SystemBioptics, Inc. · 2005
- 3 generations backK071233 Xpert 40 Specimen Radiography SystemKub Technologies, Inc. · 2007
- 2 generations backK083510 Kubtec Xpert 20Kub Technologies, Inc. · 2009
- 1 generation backK111508 Trident Specimen Radiography System, Model : RC Tri-00001Hologic, Inc. · 2011
- This deviceK163052 Brevera Biopsy System with Corlumina Imaging TechnologyHologic, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK262792 Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)Hologic, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K262792Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)Hologic, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K021113 | Mammopath | Fischer Imaging Corp. | 2002 | — |
| −4 | K052433 | Pixarray 100 Digital Specimen Radiography (DSR) System | Bioptics, Inc. | 2005 | — |
| −3 | K071233 | Xpert 40 Specimen Radiography System | Kub Technologies, Inc. | 2007 | — |
| −2 | K083510 | Kubtec Xpert 20 | Kub Technologies, Inc. | 2009 | — |
| −1 | K111508 | Trident Specimen Radiography System, Model : RC Tri-00001 | Hologic, Inc. | 2011 | — |
| 0 (this device) | K163052 | Brevera Biopsy System with Corlumina Imaging Technology | Hologic, Inc. | 2017 | — |
| +1 | K262792 | Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) | Hologic, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 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? (2)
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 |
|---|---|---|---|
| * | K042290 | Vacuum Assisted Core Biopsy DeviceSummary page 4…: II 4. Predicate Device: Tradename: ATEC handpiece and ATEC Sapphire console Submitter / 510(k) Holder: Hologic, Inc. 510(k) #’s: K042290 Tradename: Trident Specimen Radiography System Submitter / 510(k) Holder: Hologic, Inc.… | 2004 |
| * | K111508 | Trident Specimen Radiography System, Model : RC Tri-00001Summary page 4…510(k) #’s: K042290 Tradename: Trident Specimen Radiography System Submitter / 510(k) Holder: Hologic, Inc. 510(k) #’s: K111508 5. Device Description: The Brevera breast biopsy system with CorLumina imaging technology enables a p… | 2011 |
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 |
|---|---|---|---|
| K262792 | Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 15, 2025 | Class II | Z-1314-2026 | Under Investigation by firm | Presence of particulates in affected devices that can be deposited into breast tissue during use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K262792 (Hologic, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K042290.
How does its category compare?
All KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Hologic Brevera breast biopsy system with CorLumina imaging technology is intended to provide breast tissue samples for diagnostic sampling of breast abnormalities. The Brevera breast biopsy system excises targeted tissue and optionally delivers in-line radiographic images of the excised tissue. The Brevera breast biopsy system is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.…
Read the full statement (168 words)
The Hologic Brevera breast biopsy system with CorLumina imaging technology is intended to provide breast tissue samples for diagnostic sampling of breast abnormalities. The Brevera breast biopsy system excises targeted tissue and optionally delivers in-line radiographic images of the excised tissue. The Brevera breast biopsy system is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (for example, fibroadenoma, fibrocystic lesion), the Brevera breast biopsy system may also be used to partially remove such palpable lesions. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of histological abnormality, for example, 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 procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163052 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163052: Brevera Biopsy System with Corlumina Imaging Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163052
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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