De Novo · Granted
GrantedImplantable Radio Frequency Transponder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unknown applicant · NRV Implantable Radio Frequency Transponder System
Granted as a new device type through De Novo. 21 later devices descend from it.
- Class
- Class II
- Product code
- NRV
- Recalls
- None
21 later devices descend from it, 3 citing it directly.
- This deviceDEN040007 Implantable Radio Frequency Transponder System ·
- Descendant · cites it directly · 14 of its ownK062450 D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd. · 2006
- Descendant · 2 generations on · 10 of its ownK072468 Modification to D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd. · 2007 · Recalled
- Descendant · 3 generations on · 9 of its ownK110507 Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd. · 2011
- Descendant · 4 generations on · 5 of its ownK161740 D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd. · 2016
- Descendant · 5 generations on · 4 of its ownK180514 Veriton NMSpectrum Dynamics Medical, Ltd. · 2018
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K062450D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd. · 2006 · cites it directly14descendants
- K072468Modification to D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd. · 2007 · 2 generations on10descendants
- K110507Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd. · 2011 · 3 generations on9descendants
- K161740D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd. · 2016 · 4 generations on5descendants
- K180514Veriton NMSpectrum Dynamics Medical, Ltd. · 2018 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN040007 | Implantable Radio Frequency Transponder System | — | ||
| +1 | K062450 | D-Spect Cardiac Scanner System | Spectrum Dynamics, Ltd. | 2006 | — |
| +2 | K072468 | Modification to D-Spect Cardiac Scanner System | Spectrum Dynamics, Ltd. | 2007 | 1 |
| +3 | K110507 | Cardiac Scanner and Processing System | Spectrum Dynamics (Israel), Ltd. | 2011 | — |
| +4 | K161740 | D-SPECT Scanner, D-SPECT L Scanner | Spectrum Dynamics Medical, Ltd. | 2016 | — |
| +5 | K180514 | Veriton NM | Spectrum Dynamics Medical, Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA De Novo database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NRV? 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? (21)
See all 213 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K062450 (Spectrum Dynamics, Ltd., 2006) has gone furthest, with 14 descendants of its own.
How does its category compare?
All NRV devicesNRV Implantable Radio Frequency Transponder System: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NRV
FDA has decided no NRV device since 2007.
Median 510(k) review, days · NRV
Too few NRV 510(k)s in any year since 2007 to give a median.
Recalls per year · NRV
No recall names NRV since 2007.
Adverse event reports per year · NRV
1in 2025
MAUDE reports naming product code NRV, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/DEN040007 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN040007: Implantable Radio Frequency Transponder System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN040007
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026