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. · NSI System, Imaging, Esophageal, Wireless, Capsule
Cleared on May 24, 2006 as substantially equivalent to DEN010002 (Given Imaging, Ltd., 2001) and 9 other predicates after a 61-day review. Its family tree reaches back 10 generations to 2001. 28 later devices descend from it.
- Decided
- May 24, 2006
- Review
- 61 days
- Class
- Class II
- Product code
- NSI
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 10 generations to DEN010002 (2001). 28 later devices descend from it, 4 citing it directly.
- Root · 10 generations backDEN010002 Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2001
- 6 generations between
- 3 generations backK041149 Given Diagnostic System with M2A Eso CapsuleGiven Imaging, Ltd. · 2004
- 2 generations backK042960 Given Diagnostic System with Pillcam EsoGiven Imaging, Ltd. · 2004
- 1 generation backK052184 Given Diagnostic SystemGiven Imaging, Ltd. · 2005
- This deviceK060805 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2006
- Descendant · cites it directly · 26 of its ownK062786 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2006
- Descendant · cites it directly · 25 of its ownK070475 Modificaton to: Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2007
- Descendant · 2 generations on · 19 of its ownK090557 Given Pillcam Platform Will Pillcam SB Capsules, Eso Capsules, Given…Given Imaging, Ltd. · 2009
- Descendant · 2 generations on · 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
Show all 10 generations
- Root · 10 generations backDEN010002 Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2001
- 9 generations backK020341 Given Diagnostic SystemGiven Imaging, Ltd. · 2002
- 8 generations backK022362 Given Diagnostics SystemGiven Imaging, Ltd. · 2002
- 7 generations backK022980 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 6 generations backK031033 Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 5 generations backK032405 Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 4 generations backK040248 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2004
- 3 generations backK041149 Given Diagnostic System with M2A Eso CapsuleGiven Imaging, Ltd. · 2004
- 2 generations backK042960 Given Diagnostic System with Pillcam EsoGiven Imaging, Ltd. · 2004
- 1 generation backK052184 Given Diagnostic SystemGiven Imaging, Ltd. · 2005
- This deviceK060805 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2006
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K062786Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2006 · cites it directly26descendants
- K070475Modificaton to: Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2007 · cites it directly25descendants
- K090557Given Pillcam Platform Will Pillcam SB Capsules, Eso Capsules, Given Agile Patency SystemGiven Imaging, Ltd. · 2009 · 2 generations on19descendants
- K091405Pillcam Platform with Pillcam SB Capsules with Pillcam SensorbeltGiven Imaging, Ltd. · 2009 · 2 generations on17descendants
- K103025Given Pillcam Platform with Rapid 6.5 / Given Pillcam Platform with Pillcam Eso 3 CapsulesGiven Imaging, Ltd. · 2011 · cites it directly12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | DEN010002 | Given Diagnostic Imaging System | Given Imaging, Ltd. | 2001 | — |
| −9 | K020341 | Given Diagnostic System | Given Imaging, Ltd. | 2002 | — |
| −8 | K022362 | Given Diagnostics System | Given Imaging, Ltd. | 2002 | — |
| −7 | K022980 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −6 | K031033 | Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −5 | K032405 | Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −4 | K040248 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2004 | — |
| −3 | 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 | — |
| 0 (this device) | K060805 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2006 | — |
| +1 | K062786 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2006 | — |
| +1 | K070475 | Modificaton to: Given Diagnostic Imaging System | Given Imaging, Ltd. | 2007 | — |
| +2 | K090557 | Given Pillcam Platform Will Pillcam SB Capsules, Eso Capsules, Given Agile… | Given Imaging, Ltd. | 2009 | — |
| +2 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 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 NSI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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…M SB Capsule) T - Given® Diagnostic System (with M2A®/PillCam cleared for marketing under K010312, K020341, K022362, K022980, K031033, K032405, K040248 and K052184. Given® Diagnostic System with PillCamTM ESO Capsule clear… | 2002 |
| * | K022362 | Given Diagnostics SystemSummary page 1…SB Capsule) T - Given® Diagnostic System (with M2A®/PillCam cleared for marketing under K010312, K020341, K022362, K022980, K031033, K032405, K040248 and K052184. Given® Diagnostic System with PillCamTM ESO Capsule cleared… | 2002 |
| * | K022980 | Modification to Given Diagnostic SystemSummary page 1…T - Given® Diagnostic System (with M2A®/PillCam cleared for marketing under K010312, K020341, K022362, K022980, K031033, K032405, K040248 and K052184. Given® Diagnostic System with PillCamTM ESO Capsule cleared under K041149 a… | 2003 |
| * | K031033 | Given Diagnostic SystemSummary page 1…T - Given® Diagnostic System (with M2A®/PillCam cleared for marketing under K010312, K020341, K022362, K022980, K031033, K032405, K040248 and K052184. Given® Diagnostic System with PillCamTM ESO Capsule cleared under K041149 and K04296… | 2003 |
| * | K032405 | Given Diagnostic SystemSummary page 1…T - Given® Diagnostic System (with M2A®/PillCam cleared for marketing under K010312, K020341, K022362, K022980, K031033, K032405, K040248 and K052184. Given® Diagnostic System with PillCamTM ESO Capsule cleared under K041149 and K042960… | 2003 |
| * | K040248 | Modification to Given Diagnostic SystemSummary page 1…T - Given® Diagnostic System (with M2A®/PillCam cleared for marketing under K010312, K020341, K022362, K022980, K031033, K032405, K040248 and K052184. Given® Diagnostic System with PillCamTM ESO Capsule cleared under K041149 and K042960… | 2004 |
| * | K052184 | Given Diagnostic SystemSummary page 1…T - Given® Diagnostic System (with M2A®/PillCam cleared for marketing under K010312, K020341, K022362, K022980, K031033, K032405, K040248 and K052184. Given® Diagnostic System with PillCamTM ESO Capsule cleared under K041149 and K042960… | 2005 |
| * | K041149 | Given Diagnostic System with M2A Eso CapsuleSummary page 1…g under K010312, K020341, K022362, K022980, K031033, K032405, K040248 and K052184. Given® Diagnostic System with PillCamTM ESO Capsule cleared under K041149 and K042960 6-3 Performance Standards and Special Controls: The Given®… | 2004 |
| * | K042960 | Given Diagnostic System with Pillcam EsoSummary page 1…312, K020341, K022362, K022980, K031033, K032405, K040248 and K052184. Given® Diagnostic System with PillCamTM ESO Capsule cleared under K041149 and K042960 6-3 Performance Standards and Special Controls: The Given® Diagnostic… | 2004 |
What descends from it? (28)
See all 284 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 5 years and passes through 1 company; a new generation was cleared every 6 months on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K062786 (Given Imaging, Ltd., 2006) has gone furthest, with 26 descendants of its own.
- 12 other devices also cite its predicate DEN010002.
How does its category compare?
All NSI devicesNSI System, Imaging, Esophageal, Wireless, Capsule: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NSI
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · NSI
Too few NSI 510(k)s in any year since 2007 to give a median.
Recalls per year · NSI
No recall names NSI since 2007.
Adverse event reports per year · NSI
1in 2023
MAUDE reports naming product code NSI, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 15 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Given® Diagnostic System with the PillCam™ SB 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
The Given® Diagnostic System with the PillCam™ ESO Capsule is intended for the visualization of esophageal mucosa.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060805 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060805: Modification to Given Diagnostic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060805
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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