510(k) · Cleared
ClearedBrevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · KNW Instrument, Biopsy
Cleared on Aug 12, 2026 as substantially equivalent to K163052 (Hologic, Inc., 2017) after a 6-day review. Its family tree reaches back 6 generations to 2002.
- Decided
- Aug 12, 2026
- Review
- 6 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K021113 (2002). 9 ancestors in all, the oldest K953404 (1995). No later device cites it as a predicate yet.
- Root · 6 generations backK021113 MammopathFischer Imaging Corp. · 2002
- 5 generations backK052433 Pixarray 100 Digital Specimen Radiography (DSR) SystemBioptics, Inc. · 2005
- 4 generations backK071233 Xpert 40 Specimen Radiography SystemKub Technologies, Inc. · 2007
- 3 generations backK083510 Kubtec Xpert 20Kub Technologies, Inc. · 2009
- 2 generations backK111508 Trident Specimen Radiography System, Model : RC Tri-00001Hologic, Inc. · 2011
- 1 generation backK163052 Brevera Biopsy System with Corlumina Imaging TechnologyHologic, Inc. · 2017 · Recalled
- This deviceK262792 Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)Hologic, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K021113 | Mammopath | Fischer Imaging Corp. | 2002 | — |
| −5 | K052433 | Pixarray 100 Digital Specimen Radiography (DSR) System | Bioptics, Inc. | 2005 | — |
| −4 | K071233 | Xpert 40 Specimen Radiography System | Kub Technologies, Inc. | 2007 | — |
| −3 | K083510 | Kubtec Xpert 20 | Kub Technologies, Inc. | 2009 | — |
| −2 | K111508 | Trident Specimen Radiography System, Model : RC Tri-00001 | Hologic, Inc. | 2011 | — |
| −1 | K163052 | Brevera Biopsy System with Corlumina Imaging Technology | Hologic, Inc. | 2017 | 1 |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K163052 | Brevera Biopsy System with Corlumina Imaging TechnologySummary page 5…General & Plastic Surgery Predicate Device Trade Name: Brevera Biopsy System with CorLumina Imaging Technology Submitter / 510(k) Holder: Hologic, Inc. 510(k) number: K163052 Device Description The Brevera breast biopsy system with CorLumina imaging technology enables a physician to utilize vacuum-ass… | 2017 |
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 24 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 2 of the 9 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 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/K262792 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262792: Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262792
Report an extraction error
Are you the manufacturer?
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