510(k) · Cleared
ClearedGiven Diagnostic System with M2A Eso Capsule
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 Oct 25, 2004 as substantially equivalent to DEN010002 (Given Imaging, Ltd., 2001) and 6 other predicates after a 175-day review. Its family tree reaches back 7 generations to 2001. 33 later devices descend from it.
- Decided
- Oct 25, 2004
- Review
- 175 days
- Class
- Class II
- Product code
- NSI
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 7 generations to DEN010002 (2001). 33 later devices descend from it, 5 citing it directly.
- Root · 7 generations backDEN010002 Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2001
- 6 generations backK020341 Given Diagnostic SystemGiven Imaging, Ltd. · 2002
- 5 generations backK022362 Given Diagnostics SystemGiven Imaging, Ltd. · 2002
- 4 generations backK022980 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 3 generations backK031033 Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 2 generations backK032405 Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 1 generation backK040248 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2004
- This deviceK041149 Given Diagnostic System with M2A Eso CapsuleGiven Imaging, Ltd. · 2004
- Descendant · cites it directly · 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 · 2 generations on · 26 of its ownK062786 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2006
- Descendant · 2 generations on · 25 of its ownK070475 Modificaton to: Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2007
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K042960Given Diagnostic System with Pillcam EsoGiven Imaging, Ltd. · 2004 · cites it directly32descendants
- 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 · 2 generations on26descendants
- K070475Modificaton to: Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2007 · 2 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | DEN010002 | Given Diagnostic Imaging System | Given Imaging, Ltd. | 2001 | — |
| −6 | K020341 | Given Diagnostic System | Given Imaging, Ltd. | 2002 | — |
| −5 | K022362 | Given Diagnostics System | Given Imaging, Ltd. | 2002 | — |
| −4 | K022980 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −3 | K031033 | Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −2 | K032405 | Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −1 | K040248 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2004 | — |
| 0 (this device) | K041149 | Given Diagnostic System with M2A Eso Capsule | Given Imaging, Ltd. | 2004 | — |
| +1 | 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 | — |
| +2 | K062786 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2006 | — |
| +2 | K070475 | Modificaton to: Given Diagnostic Imaging System | Given Imaging, Ltd. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 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 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? (7)
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…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, and K040248.) Performance Standards and Special Controls:… | 2002 |
| * | K022362 | Given Diagnostics SystemSummary page 1…m 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, and K040248.) Performance Standards and Special Controls:… | 2002 |
| * | K022980 | Modification to Given Diagnostic SystemSummary page 1…s II devices (product code 78NZE) and they are reviewed by the Gastroenterology Panel. Predicate Device: Given® Diagnostic System (K010312, K020341, K022362, K022980, K031033, K032405, and K040248.) Performance Standards and Special Controls:… | 2003 |
| * | K031033 | Given Diagnostic SystemSummary page 1…ces (product code 78NZE) and they are reviewed by the Gastroenterology Panel. Predicate Device: Given® Diagnostic System (K010312, K020341, K022362, K022980, K031033, K032405, and K040248.) Performance Standards and Special Controls:… | 2003 |
| * | K032405 | Given Diagnostic SystemSummary page 1…ode 78NZE) and they are reviewed by the Gastroenterology Panel. Predicate Device: Given® Diagnostic System (K010312, K020341, K022362, K022980, K031033, K032405, and K040248.) Performance Standards and Special Controls:… | 2003 |
| * | K040248 | Modification to Given Diagnostic SystemSummary page 1…d they are reviewed by the Gastroenterology Panel. Predicate Device: Given® Diagnostic System (K010312, K020341, K022362, K022980, K031033, K032405, and K040248.) Performance Standards and Special Controls:… | 2004 |
What descends from it? (33)
See all 335 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 3 years and passes through 1 company; a new generation was cleared every 4 months on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K042960 (Given Imaging, Ltd., 2004) has gone furthest, with 32 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 PillCamTM ESO Capsule is intended for the
visualization of the esophagus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041149 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041149: Given Diagnostic System with M2A Eso Capsule.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041149
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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