510(k) · Cleared
ClearedGiven Pillcam Ugi Capsule Endoscopy 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 Dec 17, 2014 as substantially equivalent to K071153 (Given Imaging, Ltd., 2007) and 3 other predicates after a 316-day review. Its family tree reaches back 16 generations to 2001.
- Decided
- Dec 17, 2014
- Review
- 316 days
- Class
- Class II
- Product code
- NEZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 16 generations to DEN010002 (2001). 21 ancestors in all. No later device cites it as a predicate yet.
- Root · 16 generations backDEN010002 Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2001
- 12 generations between
- 3 generations backK090557 Given Pillcam Platform Will Pillcam SB Capsules, Eso Capsules, Given…Given Imaging, Ltd. · 2009
- 2 generations backK101250 Given Pillcam Platform with Pillcam SB CapsulesGiven Imaging, Ltd. · 2011
- 1 generation backK123864 Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam SB 3…Given Imaging, Ltd. · 2013
- This deviceK140284 Given Pillcam Ugi Capsule Endoscopy SystemGiven Imaging, Ltd. · 2014
Show all 16 generations
- Root · 16 generations backDEN010002 Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2001
- 15 generations backK020341 Given Diagnostic SystemGiven Imaging, Ltd. · 2002
- 14 generations backK022362 Given Diagnostics SystemGiven Imaging, Ltd. · 2002
- 13 generations backK022980 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 12 generations backK031033 Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 11 generations backK032405 Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 10 generations backK040248 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2004
- 9 generations backK041149 Given Diagnostic System with M2A Eso CapsuleGiven Imaging, Ltd. · 2004
- 8 generations backK042960 Given Diagnostic System with Pillcam EsoGiven Imaging, Ltd. · 2004
- 7 generations backK052184 Given Diagnostic SystemGiven Imaging, Ltd. · 2005
- 6 generations backK060805 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2006
- 5 generations backK062786 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2006
- 4 generations backK070475 Modificaton to: Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2007
- 3 generations backK090557 Given Pillcam Platform Will Pillcam SB Capsules, Eso Capsules, Given…Given Imaging, Ltd. · 2009
- 2 generations backK101250 Given Pillcam Platform with Pillcam SB CapsulesGiven Imaging, Ltd. · 2011
- 1 generation backK123864 Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam SB 3…Given Imaging, Ltd. · 2013
- This deviceK140284 Given Pillcam Ugi Capsule Endoscopy SystemGiven Imaging, Ltd. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | DEN010002 | Given Diagnostic Imaging System | Given Imaging, Ltd. | 2001 | — |
| −15 | K020341 | Given Diagnostic System | Given Imaging, Ltd. | 2002 | — |
| −14 | K022362 | Given Diagnostics System | Given Imaging, Ltd. | 2002 | — |
| −13 | K022980 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −12 | K031033 | Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −11 | K032405 | Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −10 | K040248 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2004 | — |
| −9 | K041149 | Given Diagnostic System with M2A Eso Capsule | Given Imaging, Ltd. | 2004 | — |
| −8 | K042960 | Given Diagnostic System with Pillcam Eso | Given Imaging, Ltd. | 2004 | — |
| −7 | K052184 | Given Diagnostic System | Given Imaging, Ltd. | 2005 | — |
| −6 | K060805 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2006 | — |
| −5 | K062786 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2006 | — |
| −4 | K070475 | Modificaton to: Given Diagnostic Imaging System | Given Imaging, Ltd. | 2007 | — |
| −3 | K090557 | Given Pillcam Platform Will Pillcam SB Capsules, Eso Capsules, Given Agile… | Given Imaging, Ltd. | 2009 | — |
| −2 | K101250 | Given Pillcam Platform with Pillcam SB Capsules | Given Imaging, Ltd. | 2011 | — |
| −1 | K123864 | Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam SB 3 Capsule… | Given Imaging, Ltd. | 2013 | — |
| 0 (this device) | K140284 | Given Pillcam Ugi Capsule Endoscopy System | Given Imaging, Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 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? (4)
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 |
|---|---|---|---|
| * | K071153 | Given Diagnostic System with Pillcam ESO2 CapsuleSummary page 4…NEZ – System, Imaging, Gastrointestinal, Wireless, Capsule Predicate Given Diagnostic System with PillCam ESO 2 capsule Device(s): (K071153) Given PillCam Platform System with RAPID 6.5 and Given PillCam Platform with E… | 2007 |
| * | K103025 | Given Pillcam Platform with Rapid 6.5 / Given Pillcam Platform with Pillcam Eso 3 CapsulesSummary page 4…s): (K071153) Given PillCam Platform System with RAPID 6.5 and Given PillCam Platform with ESO 3 capsule (K103025) Given PillCam® SB 3 capsule endoscopy system (K123864) Given PillCam® COLON 2… | 2011 |
| * | K123864 | Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam SB 3 Capsule Endoscopy SystemSummary page 4…em with RAPID 6.5 and Given PillCam Platform with ESO 3 capsule (K103025) Given PillCam® SB 3 capsule endoscopy system (K123864) Given PillCam® COLON 2 capsule endoscopy system (K123666) Given Imaging… | 2013 |
| * | DEN120023 | Given Pillcam Colon 2 Capsule Endoscopy System Our reading of the summary gave K123666, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN120023, Given Pillcam Colon 2 Capsule Endoscopy System (Given Imaging, Ltd.), granted Jan 29, 2014; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 13 years and passes through 1 company; a new generation was cleared every 7 months on median.
- None of the 21 ancestors has a recall.
- 1 other device also cites its predicate K071153.
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. 2014, 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 PillCam UGI capsule endoscopy system is intended for visualization of the upper gastrointestinal tract (esophagus, stomach, duodenum). It may be used for visualization of blood in the upper gastrointestinal tract (esophagus, stomach, duodenum) in patients who are hemodynamically stable and at least18 years of age.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140284 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140284: Given Pillcam Ugi Capsule Endoscopy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140284
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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