510(k) · Cleared
ClearedModificaton to: Given 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
Cleared on May 7, 2007 as substantially equivalent to DEN010002 (Given Imaging, Ltd., 2001) and 9 other predicates after a 76-day review. Its family tree reaches back 12 generations to 2001. 25 later devices descend from it.
- Decided
- May 7, 2007
- Review
- 76 days
- Class
- Class II
- Product code
- NEZ
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 12 generations to DEN010002 (2001). 25 later devices descend from it, 5 citing it directly.
- Root · 12 generations backDEN010002 Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2001
- 8 generations between
- 3 generations backK052184 Given Diagnostic SystemGiven Imaging, Ltd. · 2005
- 2 generations backK060805 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2006
- 1 generation backK062786 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2006
- This deviceK070475 Modificaton to: Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2007
- Descendant · cites it directly · 19 of its ownK090557 Given Pillcam Platform Will Pillcam SB Capsules, Eso Capsules, Given…Given Imaging, Ltd. · 2009
- Descendant · cites it directly · 17 of its ownK091405 Pillcam Platform with Pillcam SB Capsules with Pillcam SensorbeltGiven Imaging, Ltd. · 2009
- Descendant · cites it directly · 12 of its ownK103025 Given Pillcam Platform with Rapid 6.5 / Given Pillcam Platform with…Given Imaging, Ltd. · 2011
- Descendant · 2 generations on · 12 of its ownK101250 Given Pillcam Platform with Pillcam SB CapsulesGiven Imaging, Ltd. · 2011
- Descendant · 2 generations on · 11 of its ownK123864 Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam SB 3…Given Imaging, Ltd. · 2013
Show all 12 generations
- Root · 12 generations backDEN010002 Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2001
- 11 generations backK020341 Given Diagnostic SystemGiven Imaging, Ltd. · 2002
- 10 generations backK022362 Given Diagnostics SystemGiven Imaging, Ltd. · 2002
- 9 generations backK022980 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 8 generations backK031033 Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 7 generations backK032405 Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 6 generations backK040248 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2004
- 5 generations backK041149 Given Diagnostic System with M2A Eso CapsuleGiven Imaging, Ltd. · 2004
- 4 generations backK042960 Given Diagnostic System with Pillcam EsoGiven Imaging, Ltd. · 2004
- 3 generations backK052184 Given Diagnostic SystemGiven Imaging, Ltd. · 2005
- 2 generations backK060805 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2006
- 1 generation backK062786 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2006
- This deviceK070475 Modificaton to: Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2007
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K090557Given Pillcam Platform Will Pillcam SB Capsules, Eso Capsules, Given Agile Patency SystemGiven Imaging, Ltd. · 2009 · cites it directly19descendants
- K091405Pillcam Platform with Pillcam SB Capsules with Pillcam SensorbeltGiven Imaging, Ltd. · 2009 · cites it directly17descendants
- K103025Given Pillcam Platform with Rapid 6.5 / Given Pillcam Platform with Pillcam Eso 3 CapsulesGiven Imaging, Ltd. · 2011 · cites it directly12descendants
- K101250Given Pillcam Platform with Pillcam SB CapsulesGiven Imaging, Ltd. · 2011 · 2 generations on12descendants
- K123864Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam SB 3 Capsule Endoscopy SystemGiven Imaging, Ltd. · 2013 · 2 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | DEN010002 | Given Diagnostic Imaging System | Given Imaging, Ltd. | 2001 | — |
| −11 | K020341 | Given Diagnostic System | Given Imaging, Ltd. | 2002 | — |
| −10 | K022362 | Given Diagnostics System | Given Imaging, Ltd. | 2002 | — |
| −9 | K022980 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −8 | K031033 | Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −7 | K032405 | Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −6 | K040248 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2004 | — |
| −5 | K041149 | Given Diagnostic System with M2A Eso Capsule | Given Imaging, Ltd. | 2004 | — |
| −4 | K042960 | Given Diagnostic System with Pillcam Eso | Given Imaging, Ltd. | 2004 | — |
| −3 | K052184 | Given Diagnostic System | Given Imaging, Ltd. | 2005 | — |
| −2 | K060805 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2006 | — |
| −1 | K062786 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2006 | — |
| 0 (this device) | K070475 | Modificaton to: Given Diagnostic Imaging System | Given Imaging, Ltd. | 2007 | — |
| +1 | K090557 | Given Pillcam Platform Will Pillcam SB Capsules, Eso Capsules, Given Agile… | Given Imaging, Ltd. | 2009 | — |
| +1 | K091405 | Pillcam Platform with Pillcam SB Capsules with Pillcam Sensorbelt | Given Imaging, Ltd. | 2009 | — |
| +1 | K103025 | Given Pillcam Platform with Rapid 6.5 / Given Pillcam Platform with Pillcam… | Given Imaging, Ltd. | 2011 | — |
| +2 | K101250 | Given Pillcam Platform with Pillcam SB Capsules | Given Imaging, Ltd. | 2011 | — |
| +2 | K123864 | Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam SB 3 Capsule… | Given Imaging, Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (10)
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…ber 21 CFR 876.1300) and they are reviewed by the Gastroenterology Panel. Predicate Device: Given® Diagnostic System cleared for marketing under K010312, K020341, K022362, K022980, K031033, K032405, K040248, K052184, K060805 and K062786 6- 3 ===… | 2002 |
| * | K022362 | Given Diagnostics SystemSummary page 1…R 876.1300) and they are reviewed by the Gastroenterology Panel. Predicate Device: Given® Diagnostic System cleared for marketing under K010312, K020341, K022362, K022980, K031033, K032405, K040248, K052184, K060805 and K062786 6- 3 === Page 2 ==… | 2002 |
| * | K022980 | Modification to Given Diagnostic SystemSummary page 1…0) and they are reviewed by the Gastroenterology Panel. Predicate Device: Given® Diagnostic System cleared for marketing under K010312, K020341, K022362, K022980, K031033, K032405, K040248, K052184, K060805 and K062786 6- 3 Perform… | 2003 |
| * | K031033 | Given Diagnostic SystemSummary page 1…ey are reviewed by the Gastroenterology Panel. Predicate Device: Given® Diagnostic System cleared for marketing under K010312, K020341, K022362, K022980, K031033, K032405, K040248, K052184, K060805 and K062786 6- 3 Performance Stan… | 2003 |
| * | K032405 | Given Diagnostic SystemSummary page 1…viewed by the Gastroenterology Panel. Predicate Device: Given® Diagnostic System cleared for marketing under K010312, K020341, K022362, K022980, K031033, K032405, K040248, K052184, K060805 and K062786 6- 3 Performance Standards and… | 2003 |
| * | K040248 | Modification to Given Diagnostic SystemSummary page 1…the Gastroenterology Panel. Predicate Device: Given® Diagnostic System cleared for marketing under K010312, K020341, K022362, K022980, K031033, K032405, K040248, K052184, K060805 and K062786 6- 3 Performance Standards and Special… | 2004 |
| * | K052184 | Given Diagnostic SystemSummary page 1…Gastroenterology Panel. Predicate Device: Given® Diagnostic System cleared for marketing under K010312, K020341, K022362, K022980, K031033, K032405, K040248, K052184, K060805 and K062786 6- 3 Performance Standards and Special Controls:… | 2005 |
| * | K060805 | Modification to Given Diagnostic SystemSummary page 1…ogy Panel. Predicate Device: Given® Diagnostic System cleared for marketing under K010312, K020341, K022362, K022980, K031033, K032405, K040248, K052184, K060805 and K062786 6- 3 Performance Standards and Special Controls: The Give… | 2006 |
| * | K062786 | Modification to Given Diagnostic SystemSummary page 1…Predicate Device: Given® Diagnostic System cleared for marketing under K010312, K020341, K022362, K022980, K031033, K032405, K040248, K052184, K060805 and K062786 6- 3 Performance Standards and Special Controls: The Given® Diagnosti… | 2006 |
What descends from it? (25)
See all 255 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090557 | Given Pillcam Platform Will Pillcam SB Capsules, Eso Capsules, Given Agile Patency System | 2009 | 19 |
| K091405 | Pillcam Platform with Pillcam SB Capsules with Pillcam Sensorbelt | 2009 | 17 |
| K103025 | Given Pillcam Platform with Rapid 6.5 / Given Pillcam Platform with Pillcam Eso 3 Capsules | 2011 | 12 |
| K111450 | Mirocam Capsule Endoscope System | 2012 | 7 |
| K151635 | CapsoCam (SV-1) | 2016 | 1 |
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 6 years and passes through 1 company; a new generation was cleared every 6 months on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K090557 (Given Imaging, Ltd., 2009) has gone furthest, with 19 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. 2007, this device’s year, is highlighted.
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 with the PillCamTM SB2 Capsule 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/K070475 · printed Nov 3, 2026
Cite this page
510(k) Report. “K070475: Modificaton to: Given Diagnostic Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K070475
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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