De Novo · Granted
GrantedGiven Diagnostic Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Given Imaging, Ltd. · NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
Granted on Aug 1, 2001 as a new device type through De Novo after a 51-day review. 40 later devices descend from it.
- Decided
- Aug 1, 2001
- Review
- 51 days
- Class
- Class II
- Product code
- NEZ
- Recalls
- None
40 later devices descend from it, 13 citing it directly.
- This deviceDEN010002 Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2001
- Descendant · cites it directly · 39 of its ownK020341 Given Diagnostic SystemGiven Imaging, Ltd. · 2002
- Descendant · cites it directly · 38 of its ownK022362 Given Diagnostics SystemGiven Imaging, Ltd. · 2002
- Descendant · cites it directly · 37 of its ownK022980 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- Descendant · cites it directly · 36 of its ownK031033 Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- Descendant · cites it directly · 35 of its ownK032405 Given Diagnostic SystemGiven Imaging, Ltd. · 2003
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K020341Given Diagnostic SystemGiven Imaging, Ltd. · 2002 · cites it directly39descendants
- K022362Given Diagnostics SystemGiven Imaging, Ltd. · 2002 · cites it directly38descendants
- K022980Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2003 · cites it directly37descendants
- K031033Given Diagnostic SystemGiven Imaging, Ltd. · 2003 · cites it directly36descendants
- K032405Given Diagnostic SystemGiven Imaging, Ltd. · 2003 · cites it directly35descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN010002 | Given Diagnostic Imaging System | Given Imaging, Ltd. | 2001 | — |
| +1 | K020341 | Given Diagnostic System | Given Imaging, Ltd. | 2002 | — |
| +1 | K022362 | Given Diagnostics System | Given Imaging, Ltd. | 2002 | — |
| +1 | K022980 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| +1 | K031033 | Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| +1 | K032405 | Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2009 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 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 NEZ? 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 NEZ device
- #1 K252617 MiroCam® Capsule Endoscope Systemscore 17.0 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (40)
See all 4013 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020341 | Given Diagnostic System | 2002 | 39 |
| K022362 | Given Diagnostics System | 2002 | 38 |
| K022980 | Modification to Given Diagnostic System | 2003 | 37 |
| K031033 | Given Diagnostic System | 2003 | 36 |
| K032405 | Given Diagnostic System | 2003 | 35 |
| K040248 | Modification to Given Diagnostic System | 2004 | 34 |
| K041149 | Given Diagnostic System with M2A Eso Capsule | 2004 | 33 |
| K052184 | Given Diagnostic System | 2005 | 30 |
| K060805 | Modification to Given Diagnostic System | 2006 | 28 |
| K062786 | Modification to Given Diagnostic System | 2006 | 26 |
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, K020341 (Given Imaging, Ltd., 2002) has gone furthest, with 39 descendants of its own.
How does its category compare?
All NEZ devicesNEZ System, Imaging, Gastrointestinal, Wireless, Capsule: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NEZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NEZ
99in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NEZ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NEZ
69in 2025
MAUDE reports naming product code NEZ, 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 | 2 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 9 |
| 2009 | 2 | — | 0 | 6 |
| 2010 | 1 | — | 0 | 13 |
| 2011 | 3 | 213 | 1 | 10 |
| 2012 | 1 | — | 0 | 19 |
| 2013 | 3 | 194 | 0 | 6 |
| 2014 | 3 | 194 | 0 | 13 |
| 2015 | 2 | — | 0 | 30 |
| 2016 | 2 | — | 0 | 57 |
| 2017 | 4 | 83 | 0 | 55 |
| 2018 | 3 | 233 | 0 | 50 |
| 2019 | 2 | — | 0 | 56 |
| 2020 | 1 | — | 0 | 31 |
| 2021 | 1 | — | 0 | 41 |
| 2022 | 1 | — | 0 | 63 |
| 2023 | 1 | — | 0 | 34 |
| 2024 | 3 | 99 | 0 | 103 |
| 2025 | 1 | — | 0 | 69 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/DEN010002 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN010002: Given Diagnostic Imaging System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN010002
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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