De Novo · Granted
GrantedXplantR Explant Tool
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hjarta Care, LLC · SHR Device For Open Surgical Explant Of Endovascular Prostheses
Granted on Apr 17, 2026 as a new device type through De Novo after a 253-day review.
- Decided
- Apr 17, 2026
- Review
- 253 days
- Product code
- SHR
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo 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 SHR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
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.
How does its category compare?
All SHR devicesSHR Device For Open Surgical Explant Of Endovascular Prostheses: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SHR
1so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · SHR
Too few SHR 510(k)s in any year since 2007 to give a median.
Recalls per year · SHR
No recall names SHR since 2007.
Adverse event reports per year · SHR
No MAUDE report names SHR since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The XplantR Explant Tool is indicated for use in open surgical conversion after endovascular abdominal aortic aneurysm repair to aid in the disengagement of the stent graft from the aorta. The XplantR is to be used when, at the discretion of the operating physician, the proximal end of the endovascular graft is to be removed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN250033 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN250033: XplantR Explant Tool.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN250033
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026