510(k) · Cleared
ClearedGiven Diagnostic 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
Cleared on May 2, 2002 as substantially equivalent to DEN010002 (Given Imaging, Ltd., 2001) after a 90-day review. Its family tree reaches back 1 generation to 2001. 39 later devices descend from it.
- Decided
- May 2, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- NEZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN010002 (2001). 39 later devices descend from it, 12 citing it directly.
- Root · 1 generation backDEN010002 Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2001
- This deviceK020341 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
- Descendant · cites it directly · 34 of its ownK040248 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2004
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- 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
- K040248Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2004 · cites it directly34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN010002 | Given Diagnostic Imaging System | Given Imaging, Ltd. | 2001 | — |
| 0 (this device) | 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 | — |
| +1 | K040248 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 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 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 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
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 |
|---|---|---|---|
| * | DEN010002 | Given Diagnostic Imaging System Our OCR of the scanned summary read K010312, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN010002, Given Diagnostic Imaging System (Given Imaging, Ltd.), granted Aug 1, 2001; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2001 |
What descends from it? (39)
See all 3912 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| 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 |
| K070475 | Modificaton to: Given Diagnostic Imaging System | 2007 | 25 |
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?
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 | — |
What is it indicated for?
The Given® Diagnostic System is intended for visualization of the small bowel mucosa. It may be used as an adjunctive tool in the detection of abnormalities of the small bowel
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020341 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020341: Given Diagnostic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020341
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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