510(k) · Cleared
ClearedModification to Given 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 Feb 17, 2004 as substantially equivalent to DEN010002 (Given Imaging, Ltd., 2001) and 5 other predicates after a 14-day review. Its family tree reaches back 6 generations to 2001. 34 later devices descend from it.
- Decided
- Feb 17, 2004
- Review
- 14 days
- Class
- Class II
- Product code
- NEZ
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 6 generations to DEN010002 (2001). 34 later devices descend from it, 6 citing it directly.
- Root · 6 generations backDEN010002 Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2001
- 5 generations backK020341 Given Diagnostic SystemGiven Imaging, Ltd. · 2002
- 4 generations backK022362 Given Diagnostics SystemGiven Imaging, Ltd. · 2002
- 3 generations backK022980 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 2 generations backK031033 Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 1 generation backK032405 Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- This deviceK040248 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
- Descendant · 2 generations on · 32 of its ownK042960 Given Diagnostic System with Pillcam EsoGiven Imaging, Ltd. · 2004
- Descendant · cites it directly · 30 of its ownK052184 Given Diagnostic SystemGiven Imaging, Ltd. · 2005
- Descendant · cites it directly · 28 of its ownK060805 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2006
- Descendant · cites it directly · 26 of its ownK062786 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2006
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K041149Given Diagnostic System with M2A Eso CapsuleGiven Imaging, Ltd. · 2004 · cites it directly33descendants
- K042960Given Diagnostic System with Pillcam EsoGiven Imaging, Ltd. · 2004 · 2 generations on32descendants
- K052184Given Diagnostic SystemGiven Imaging, Ltd. · 2005 · cites it directly30descendants
- K060805Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2006 · cites it directly28descendants
- K062786Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2006 · cites it directly26descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | DEN010002 | Given Diagnostic Imaging System | Given Imaging, Ltd. | 2001 | — |
| −5 | K020341 | Given Diagnostic System | Given Imaging, Ltd. | 2002 | — |
| −4 | K022362 | Given Diagnostics System | Given Imaging, Ltd. | 2002 | — |
| −3 | K022980 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −2 | K031033 | Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −1 | K032405 | Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| 0 (this device) | K040248 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2004 | — |
| +1 | K041149 | Given Diagnostic System with M2A Eso Capsule | Given Imaging, Ltd. | 2004 | — |
| +2 | K042960 | Given Diagnostic System with Pillcam Eso | Given Imaging, Ltd. | 2004 | — |
| +1 | K052184 | Given Diagnostic System | Given Imaging, Ltd. | 2005 | — |
| +1 | K060805 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2006 | — |
| +1 | K062786 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 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? (6)
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 1…ng System as class II devices (product code 78NZE) and they are reviewed by the Gastroenterology Panel. Predicate Device: · Given® Diagnostic System (K010312, K020341, K022362, K022980, K031033, K032405) Performance Standards and Special Controls: The Given® Diagnostic System complies… | 2002 |
| * | K022362 | Given Diagnostics SystemSummary page 1…as class II devices (product code 78NZE) and they are reviewed by the Gastroenterology Panel. Predicate Device: · Given® Diagnostic System (K010312, K020341, K022362, K022980, K031033, K032405) Performance Standards and Special Controls: The Given® Diagnostic System complies with the… | 2002 |
| * | K022980 | Modification to Given Diagnostic SystemSummary page 1…II devices (product code 78NZE) and they are reviewed by the Gastroenterology Panel. Predicate Device: · Given® Diagnostic System (K010312, K020341, K022362, K022980, K031033, K032405) Performance Standards and Special Controls: The Given® Diagnostic System complies with the requirem… | 2003 |
| * | K031033 | Given Diagnostic SystemSummary page 1…roduct code 78NZE) and they are reviewed by the Gastroenterology Panel. Predicate Device: · Given® Diagnostic System (K010312, K020341, K022362, K022980, K031033, K032405) Performance Standards and Special Controls: The Given® Diagnostic System complies with the requirements pres… | 2003 |
| * | K032405 | Given Diagnostic SystemSummary page 1…de 78NZE) and they are reviewed by the Gastroenterology Panel. Predicate Device: · Given® Diagnostic System (K010312, K020341, K022362, K022980, K031033, K032405) Performance Standards and Special Controls: The Given® Diagnostic System complies with the requirements presented in… | 2003 |
What descends from it? (34)
See all 346 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| 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 3 years and passes through 1 company; a new generation was cleared every 4 months on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K041149 (Given Imaging, Ltd., 2004) has gone furthest, with 33 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 a tool in the detection of abnormalities of the small bowel in adults and children from 10 years of age and up.
The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040248 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040248: Modification to Given Diagnostic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040248
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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