510(k) · Cleared
ClearedKubtec Xpert 20
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kub Technologies, Inc. · KPR System, X-Ray, Stationary
Cleared on Jan 8, 2009 as substantially equivalent to K071233 (Kub Technologies, Inc., 2007) after a 43-day review. Its family tree reaches back 3 generations to 2002. 15 later devices descend from it.
- Decided
- Jan 8, 2009
- Review
- 43 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K021113 (2002). 5 ancestors in all, the oldest K953404 (1995). 15 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK021113 MammopathFischer Imaging Corp. · 2002
- 2 generations backK052433 Pixarray 100 Digital Specimen Radiography (DSR) SystemBioptics, Inc. · 2005
- 1 generation backK071233 Xpert 40 Specimen Radiography SystemKub Technologies, Inc. · 2007
- This deviceK083510 Kubtec Xpert 20Kub Technologies, Inc. · 2009
- Descendant · cites it directly · 14 of its ownK111508 Trident Specimen Radiography System, Model : RC Tri-00001Hologic, Inc. · 2011
- Descendant · 2 generations on · 4 of its ownK122428 Faxitron Specien Radiography SystemFaxitron Bioptics, LLC · 2012
- Descendant · 2 generations on · 3 of its ownK182727 Trident HD Specimen Radiography SystemHologic, Inc. · 2019
- Descendant · 3 generations on · 2 of its ownK202713 TrueView 100 ProCompai Healthcare (Shenzhen) Co.,Ltd · 2020
- Descendant · 3 generations on · 2 of its ownK170786 Faxitron Bioptics Speciemen Radiography SystemFaxitron Bioptics, LLC · 2017
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K111508Trident Specimen Radiography System, Model : RC Tri-00001Hologic, Inc. · 2011 · cites it directly14descendants
- K122428Faxitron Specien Radiography SystemFaxitron Bioptics, LLC · 2012 · 2 generations on4descendants
- K182727Trident HD Specimen Radiography SystemHologic, Inc. · 2019 · 2 generations on3descendants
- K202713TrueView 100 ProCompai Healthcare (Shenzhen) Co.,Ltd · 2020 · 3 generations on2descendants
- K170786Faxitron Bioptics Speciemen Radiography SystemFaxitron Bioptics, LLC · 2017 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K021113 | Mammopath | Fischer Imaging Corp. | 2002 | — |
| −2 | K052433 | Pixarray 100 Digital Specimen Radiography (DSR) System | Bioptics, Inc. | 2005 | — |
| −1 | K071233 | Xpert 40 Specimen Radiography System | Kub Technologies, Inc. | 2007 | — |
| 0 (this device) | K083510 | Kubtec Xpert 20 | Kub Technologies, Inc. | 2009 | — |
| +1 | K111508 | Trident Specimen Radiography System, Model : RC Tri-00001 | Hologic, Inc. | 2011 | — |
| +2 | K122428 | Faxitron Specien Radiography System | Faxitron Bioptics, LLC | 2012 | — |
| +2 | K182727 | Trident HD Specimen Radiography System | Hologic, Inc. | 2019 | — |
| +3 | K202713 | TrueView 100 Pro | Compai Healthcare (Shenzhen) Co.,Ltd | 2020 | — |
| +3 | K170786 | Faxitron Bioptics Speciemen Radiography System | Faxitron Bioptics, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2023 | 2 | 0 |
| 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 KPR? 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 KPR device
- #1 K242119 Innovision-Exiiscore 17.0 · 9 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 |
|---|---|---|---|
| * | K071233 | Xpert 40 Specimen Radiography SystemSummary page 2…ography System > XPERT 20 Specimen X-Ray System / Cabinet Class 11, Product Code MWP,-21 CFR 892.1680 Predicate Device [21 CFR 807.92(a)(3)] o XPERT 40 (K071233) Description of the Device [21 CFR 807.92(a)(4)] The XPERT Specimen Radiography System is a self contained, shielded cabi… | 2007 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111508 | Trident Specimen Radiography System, Model : RC Tri-00001 | 2011 | 14 |
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 7 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K111508 (Hologic, Inc., 2011) has gone furthest, with 14 descendants of its own.
- 4 other devices also cite its predicate K071233.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · KPR
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPR
155in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPR
7in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPR
39in 2025
MAUDE reports naming product code KPR, 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 | 12 | 31 | 10 | 120 |
| 2008 | 15 | 48 | 10 | 95 |
| 2009 | 9 | 35 | 5 | 61 |
| 2010 | 9 | 126 | 3 | 82 |
| 2011 | 9 | 152 | 5 | 103 |
| 2012 | 11 | 58 | 1 | 74 |
| 2013 | 5 | 163 | 5 | 24 |
| 2014 | 10 | 108 | 8 | 34 |
| 2015 | 18 | 81 | 1 | 59 |
| 2016 | 11 | 84 | 4 | 18 |
| 2017 | 6 | 75 | 3 | 31 |
| 2018 | 15 | 30 | 4 | 36 |
| 2019 | 12 | 33 | 1 | 77 |
| 2020 | 16 | 39 | 1 | 41 |
| 2021 | 6 | 55 | 0 | 37 |
| 2022 | 8 | 43 | 2 | 27 |
| 2023 | 9 | 76 | 4 | 39 |
| 2024 | 11 | 162 | 1 | 34 |
| 2025 | 8 | 155 | 7 | 39 |
| 2026 | 6 | 197 | 0 | — |
What is it indicated for?
Provide digital x-ray images of harvested tissue specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083510 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083510: Kubtec Xpert 20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083510
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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