PMA · Approved
ApprovedValitude, Valitude X4, Visionist, Visionist X4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guidant Corp. · NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
Approved on Jun 3, 2026 through premarket approval, which rests on the device’s own clinical evidence after a 30-day review.
- Decided
- Jun 3, 2026
- Review
- 30 days
- Class
- Class III
- Product code
- NKE
- Recalls
- None
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NKE? 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?
PMA 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 NKE devicesNKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P): FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · NKE
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKE
Too few NKE 510(k)s in any year since 2007 to give a median.
Recalls per year · NKE
5in 2025
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · NKE
1,939in 2025
MAUDE reports naming product code NKE, 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 | 19 | — | 0 | 37 |
| 2008 | 24 | — | 0 | 52 |
| 2009 | 22 | — | 0 | 81 |
| 2010 | 27 | — | 0 | 169 |
| 2011 | 29 | — | 0 | 196 |
| 2012 | 19 | — | 0 | 164 |
| 2013 | 44 | — | 0 | 207 |
| 2014 | 54 | — | 0 | 127 |
| 2015 | 58 | — | 1 | 356 |
| 2016 | 33 | — | 0 | 514 |
| 2017 | 48 | — | 7 | 607 |
| 2018 | 29 | — | 0 | 1,004 |
| 2019 | 29 | — | 0 | 794 |
| 2020 | 30 | — | 0 | 806 |
| 2021 | 26 | — | 0 | 1,177 |
| 2022 | 24 | — | 0 | 1,290 |
| 2023 | 27 | — | 0 | 1,469 |
| 2024 | 23 | — | 2 (2) | 1,518 |
| 2025 | 22 | — | 5 (5) | 1,939 |
| 2026 | 19 | — | 1 (1) | — |
https://510kreport.com/device/P030005/S254 · printed Nov 6, 2026
Cite this page
510(k) Report. “P030005/S254: Valitude, Valitude X4, Visionist, Visionist X4.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P030005/S254
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Record history
- FDA decision record loaded Oct 30, 2026
- Page last updated Nov 3, 2026