510(k) · Cleared
ClearedGiven Diagnostic System with Pillcam ESO2 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 Jun 11, 2007 as substantially equivalent to K041149 (Given Imaging, Ltd., 2004) and 1 other predicate after a 47-day review. Its family tree reaches back 9 generations to 2001. 13 later devices descend from it.
- Decided
- Jun 11, 2007
- Review
- 47 days
- Class
- Class II
- Product code
- NSI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to DEN010002 (2001). 13 later devices descend from it, 2 citing it directly.
- Root · 9 generations backDEN010002 Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2001
- 5 generations between
- 3 generations backK040248 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2004
- 2 generations backK041149 Given Diagnostic System with M2A Eso CapsuleGiven Imaging, Ltd. · 2004
- 1 generation backK042960 Given Diagnostic System with Pillcam EsoGiven Imaging, Ltd. · 2004
- This deviceK071153 Given Diagnostic System with Pillcam ESO2 CapsuleGiven Imaging, Ltd. · 2007
- 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 · 11 of its ownK123864 Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam SB 3…Given Imaging, Ltd. · 2013
- Descendant · 3 generations on · 4 of its ownK170210 PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0Given Imaging, Ltd. · 2017
- Descendant · 3 generations on · 3 of its ownK211684 PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EGiven Imaging Ltd. (Medtronic) · 2021
- Descendant · 3 generations on · 2 of its ownK170438 MiroCam Capsule Endoscope SystemIntromedic Co., Ltd. · 2018
Show all 9 generations
- Root · 9 generations backDEN010002 Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2001
- 8 generations backK020341 Given Diagnostic SystemGiven Imaging, Ltd. · 2002
- 7 generations backK022362 Given Diagnostics SystemGiven Imaging, Ltd. · 2002
- 6 generations backK022980 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 5 generations backK031033 Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 4 generations backK032405 Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 3 generations backK040248 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2004
- 2 generations backK041149 Given Diagnostic System with M2A Eso CapsuleGiven Imaging, Ltd. · 2004
- 1 generation backK042960 Given Diagnostic System with Pillcam EsoGiven Imaging, Ltd. · 2004
- This deviceK071153 Given Diagnostic System with Pillcam ESO2 CapsuleGiven Imaging, Ltd. · 2007
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K103025Given Pillcam Platform with Rapid 6.5 / Given Pillcam Platform with Pillcam Eso 3 CapsulesGiven Imaging, Ltd. · 2011 · cites it directly12descendants
- K123864Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam SB 3 Capsule Endoscopy SystemGiven Imaging, Ltd. · 2013 · 2 generations on11descendants
- K170210PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0Given Imaging, Ltd. · 2017 · 3 generations on4descendants
- K211684PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EGiven Imaging Ltd. (Medtronic) · 2021 · 3 generations on3descendants
- K170438MiroCam Capsule Endoscope SystemIntromedic Co., Ltd. · 2018 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | DEN010002 | Given Diagnostic Imaging System | Given Imaging, Ltd. | 2001 | — |
| −8 | K020341 | Given Diagnostic System | Given Imaging, Ltd. | 2002 | — |
| −7 | K022362 | Given Diagnostics System | Given Imaging, Ltd. | 2002 | — |
| −6 | K022980 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −5 | K031033 | Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −4 | K032405 | Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −3 | K040248 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2004 | — |
| −2 | K041149 | Given Diagnostic System with M2A Eso Capsule | Given Imaging, Ltd. | 2004 | — |
| −1 | K042960 | Given Diagnostic System with Pillcam Eso | Given Imaging, Ltd. | 2004 | — |
| 0 (this device) | K071153 | Given Diagnostic System with Pillcam ESO2 Capsule | Given Imaging, Ltd. | 2007 | — |
| +1 | K103025 | Given Pillcam Platform with Rapid 6.5 / Given Pillcam Platform with Pillcam… | Given Imaging, Ltd. | 2011 | — |
| +2 | K123864 | Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam SB 3 Capsule… | Given Imaging, Ltd. | 2013 | — |
| +3 | K170210 | PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 | Given Imaging, Ltd. | 2017 | — |
| +3 | K211684 | PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E | Given Imaging Ltd. (Medtronic) | 2021 | — |
| +3 | K170438 | MiroCam Capsule Endoscope System | Intromedic Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K041149 | Given Diagnostic System with M2A Eso CapsuleSummary page 1…6.1300) and they are reviewed by the Gastroenterology Panel. Predicate Device: Given® Diagnostic System with PillCamTM ESO Capsule cleared for marketing under K041149 and K042960 Performance Standards and Special Controls: The Given® Diagnostic System complies with the requirements pr… | 2004 |
| * | K042960 | Given Diagnostic System with Pillcam EsoSummary page 1…they are reviewed by the Gastroenterology Panel. Predicate Device: Given® Diagnostic System with PillCamTM ESO Capsule cleared for marketing under K041149 and K042960 Performance Standards and Special Controls: The Given® Diagnostic System complies with the requirements presented in "… | 2004 |
What descends from it? (13)
See all 132 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 6 years and passes through 1 company; a new generation was cleared every 4 months on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K103025 (Given Imaging, Ltd., 2011) has gone furthest, with 12 descendants of its own.
- 4 other devices also cite its predicate K041149.
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. 2007, this device’s year, is highlighted.
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 ESO2 Capsule is intended for visualization of the esophageal mucosa
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071153 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071153: Given Diagnostic System with Pillcam ESO2 Capsule.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071153
Report an extraction error
Are you the manufacturer?
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