510(k) · Cleared
ClearedGiven Diagnostics 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 Aug 9, 2002 as substantially equivalent to DEN010002 (Given Imaging, Ltd., 2001) and 1 other predicate after an 18-day review. Its family tree reaches back 2 generations to 2001. 38 later devices descend from it.
- Decided
- Aug 9, 2002
- Review
- 18 days
- Class
- Class II
- Product code
- NEZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to DEN010002 (2001). 38 later devices descend from it, 11 citing it directly.
- Root · 2 generations backDEN010002 Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2001
- 1 generation backK020341 Given Diagnostic SystemGiven Imaging, Ltd. · 2002
- This deviceK022362 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
- Descendant · cites it directly · 33 of its ownK041149 Given Diagnostic System with M2A Eso CapsuleGiven Imaging, Ltd. · 2004
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- 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
- K041149Given Diagnostic System with M2A Eso CapsuleGiven Imaging, Ltd. · 2004 · cites it directly33descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN010002 | Given Diagnostic Imaging System | Given Imaging, Ltd. | 2001 | — |
| −1 | K020341 | Given Diagnostic System | Given Imaging, Ltd. | 2002 | — |
| 0 (this device) | 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 | — |
| +1 | K041149 | Given Diagnostic System with M2A Eso Capsule | Given Imaging, Ltd. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 reading of the summary gave 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 |
| * | K020341 | Given Diagnostic SystemSummary page 2…Pantl. 6-3 Predicate Device: GivenO Diagnostic Imaging System (KO 103 12) Given@ Diagnostic System (K020341) Performance Standards a n d Special Controls: The GivenO Diagnostic System complies with the requirements presented… | 2002 |
What descends from it? (38)
See all 3811 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| 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 |
| K053639 | Given Diagnostic System | 2006 | 20 |
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?
- The line of descent spans 1 year and passes through 1 company; a new generation was cleared every 9 months on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K022980 (Given Imaging, Ltd., 2003) has gone furthest, with 37 descendants of its own.
- 12 other devices also cite its predicate DEN010002.
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 as stated in the FDA summary.
https://510kreport.com/device/K022362 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022362: Given Diagnostics System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022362
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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