510(k) · Cleared
ClearedGiven 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 May 8, 2006 as substantially equivalent to DEN010002 (Given Imaging, Ltd., 2001) and 9 other predicates after a 129-day review. Its family tree reaches back 10 generations to 2001. 20 later devices descend from it.
- Decided
- May 8, 2006
- Review
- 129 days
- Class
- Class II
- Product code
- NEZ
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 10 generations to DEN010002 (2001). 20 later devices descend from it, 1 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 deviceK053639 Given Diagnostic SystemGiven Imaging, Ltd. · 2006
- Descendant · cites it directly · 19 of its ownK090557 Given Pillcam Platform Will Pillcam SB Capsules, Eso Capsules, Given…Given Imaging, Ltd. · 2009
- Descendant · 2 generations on · 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 · 3 generations on · 11 of its ownK123864 Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam SB 3…Given Imaging, Ltd. · 2013
- Descendant · 2 generations on · 6 of its ownK103088 Given Pillcam Platform with Pillcam SB Capsuleswith Pillcam R…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 deviceK053639 Given Diagnostic SystemGiven Imaging, Ltd. · 2006
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K090557Given Pillcam Platform Will Pillcam SB Capsules, Eso Capsules, Given Agile Patency SystemGiven Imaging, Ltd. · 2009 · cites it directly19descendants
- K103025Given Pillcam Platform with Rapid 6.5 / Given Pillcam Platform with Pillcam Eso 3 CapsulesGiven Imaging, Ltd. · 2011 · 2 generations on12descendants
- 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 · 3 generations on11descendants
- K103088Given Pillcam Platform with Pillcam SB Capsuleswith Pillcam R SensorbeltGiven Imaging, Ltd. · 2011 · 2 generations on6descendants
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) | K053639 | Given Diagnostic System | Given Imaging, Ltd. | 2006 | — |
| +1 | K090557 | Given Pillcam Platform Will Pillcam SB Capsules, Eso Capsules, Given Agile… | Given Imaging, Ltd. | 2009 | — |
| +2 | 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 | — |
| +3 | K123864 | Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam SB 3 Capsule… | Given Imaging, Ltd. | 2013 | — |
| +2 | K103088 | Given Pillcam Platform with Pillcam SB Capsuleswith Pillcam R Sensorbelt | Given Imaging, Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 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…vice: The Given AGILE Patency System is an accessory for the Given® Diagnostic System with Pi1lCamTFm Capsules (Given Imaging Ltd.) cleared under K(010312, K020341, K022362, K(022980, 1(031033, K032405, K(040248, K041149, K042960, and K052184. .7-3… | 2002 |
| * | K022362 | Given Diagnostics SystemSummary page 1…The Given AGILE Patency System is an accessory for the Given® Diagnostic System with Pi1lCamTFm Capsules (Given Imaging Ltd.) cleared under K(010312, K020341, K022362, K(022980, 1(031033, K032405, K(040248, K041149, K042960, and K052184. .7-3 === Page… | 2002 |
| * | K022980 | Modification to Given Diagnostic SystemSummary page 1…AGILE Patency System is an accessory for the Given® Diagnostic System with Pi1lCamTFm Capsules (Given Imaging Ltd.) cleared under K(010312, K020341, K022362, K(022980, 1(031033, K032405, K(040248, K041149, K042960, and K052184. .7-3 Inte… | 2003 |
| * | K031033 | Given Diagnostic SystemSummary page 1…ency System is an accessory for the Given® Diagnostic System with Pi1lCamTFm Capsules (Given Imaging Ltd.) cleared under K(010312, K020341, K022362, K(022980, 1(031033, K032405, K(040248, K041149, K042960, and K052184. .7-3 Intended Use:… | 2003 |
| * | K032405 | Given Diagnostic SystemSummary page 1…s an accessory for the Given® Diagnostic System with Pi1lCamTFm Capsules (Given Imaging Ltd.) cleared under K(010312, K020341, K022362, K(022980, 1(031033, K032405, K(040248, K041149, K042960, and K052184. .7-3 Intended Use: The Given… | 2003 |
| * | K040248 | Modification to Given Diagnostic SystemSummary page 1…ory for the Given® Diagnostic System with Pi1lCamTFm Capsules (Given Imaging Ltd.) cleared under K(010312, K020341, K022362, K(022980, 1(031033, K032405, K(040248, K041149, K042960, and K052184. .7-3 Intended Use: The Given® AGILE Pa… | 2004 |
| * | K041149 | Given Diagnostic System with M2A Eso CapsuleSummary page 1…the Given® Diagnostic System with Pi1lCamTFm Capsules (Given Imaging Ltd.) cleared under K(010312, K020341, K022362, K(022980, 1(031033, K032405, K(040248, K041149, K042960, and K052184. .7-3 Intended Use: The Given® AGILE Patency Sys… | 2004 |
| * | K042960 | Given Diagnostic System with Pillcam EsoSummary page 1…® Diagnostic System with Pi1lCamTFm Capsules (Given Imaging Ltd.) cleared under K(010312, K020341, K022362, K(022980, 1(031033, K032405, K(040248, K041149, K042960, and K052184. .7-3 Intended Use: The Given® AGILE Patency System is an… | 2004 |
| * | K052184 | Given Diagnostic SystemSummary page 1…stic System with Pi1lCamTFm Capsules (Given Imaging Ltd.) cleared under K(010312, K020341, K022362, K(022980, 1(031033, K032405, K(040248, K041149, K042960, and K052184. .7-3 Intended Use: The Given® AGILE Patency System is an accessory to… | 2005 |
What descends from it? (20)
See all 201 later device cites 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 |
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 5 months on median.
- None of the 10 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.
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® AGILE Patency System is an accessory to the PillCam video capsule and is intended to verify adequate patency of the gastrointestinal tract prior to administration of the PillCam video capsule in patients with known or suspected strictures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053639 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053639: Given Diagnostic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053639
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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