510(k) · Cleared
ClearedPillCam Patency 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 Mar 8, 2018 as substantially equivalent to K090557 (Given Imaging, Ltd., 2009) after a 45-day review. Its family tree reaches back 14 generations to 2001.
- Decided
- Mar 8, 2018
- Review
- 45 days
- Class
- Class II
- Product code
- NSI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to DEN010002 (2001). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 14 generations backDEN010002 Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2001
- 10 generations between
- 3 generations backK062786 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2006
- 2 generations backK070475 Modificaton to: Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2007
- 1 generation backK090557 Given Pillcam Platform Will Pillcam SB Capsules, Eso Capsules, Given…Given Imaging, Ltd. · 2009
- This deviceK180171 PillCam Patency SystemGiven Imaging, Ltd. · 2018
Show all 14 generations
- Root · 14 generations backDEN010002 Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2001
- 13 generations backK020341 Given Diagnostic SystemGiven Imaging, Ltd. · 2002
- 12 generations backK022362 Given Diagnostics SystemGiven Imaging, Ltd. · 2002
- 11 generations backK022980 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 10 generations backK031033 Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 9 generations backK032405 Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 8 generations backK040248 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2004
- 7 generations backK041149 Given Diagnostic System with M2A Eso CapsuleGiven Imaging, Ltd. · 2004
- 6 generations backK042960 Given Diagnostic System with Pillcam EsoGiven Imaging, Ltd. · 2004
- 5 generations backK052184 Given Diagnostic SystemGiven Imaging, Ltd. · 2005
- 4 generations backK060805 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2006
- 3 generations backK062786 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2006
- 2 generations backK070475 Modificaton to: Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2007
- 1 generation backK090557 Given Pillcam Platform Will Pillcam SB Capsules, Eso Capsules, Given…Given Imaging, Ltd. · 2009
- This deviceK180171 PillCam Patency SystemGiven Imaging, Ltd. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | DEN010002 | Given Diagnostic Imaging System | Given Imaging, Ltd. | 2001 | — |
| −13 | K020341 | Given Diagnostic System | Given Imaging, Ltd. | 2002 | — |
| −12 | K022362 | Given Diagnostics System | Given Imaging, Ltd. | 2002 | — |
| −11 | K022980 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −10 | K031033 | Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −9 | K032405 | Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −8 | K040248 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2004 | — |
| −7 | K041149 | Given Diagnostic System with M2A Eso Capsule | Given Imaging, Ltd. | 2004 | — |
| −6 | K042960 | Given Diagnostic System with Pillcam Eso | Given Imaging, Ltd. | 2004 | — |
| −5 | K052184 | Given Diagnostic System | Given Imaging, Ltd. | 2005 | — |
| −4 | K060805 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2006 | — |
| −3 | K062786 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2006 | — |
| −2 | K070475 | Modificaton to: Given Diagnostic Imaging System | Given Imaging, Ltd. | 2007 | — |
| −1 | K090557 | Given Pillcam Platform Will Pillcam SB Capsules, Eso Capsules, Given Agile… | Given Imaging, Ltd. | 2009 | — |
| 0 (this device) | K180171 | PillCam Patency System | Given Imaging, Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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? (1)
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 |
|---|---|---|---|
| * | K090557 | Given Pillcam Platform Will Pillcam SB Capsules, Eso Capsules, Given Agile Patency SystemSummary page 5…Page 2 of 4 III. PREDICATE DEVICE(S) Given AGILE Patency System and Given Platform with PillCam SB Capsules (K090557) IV. DEVICE DESCRIPTION: There is no change between the Predicate device (K090557) and PillCam Patency System. The PillCa… | 2009 |
| † | K053639 | Given Diagnostic System | 2006 |
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 17 years and passes through 1 company; a new generation was cleared every 7 months on median.
- None of the 15 ancestors has a recall.
- 3 other devices also cite its predicate K090557.
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. 2018, 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 PillCam 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. The PillCam Patency capsule should only be used within the specified patient age range based on the patient age of the indicated video capsule system.
Therefore, the PillCam Patency System is intended to be used:
• prior to PillCam SB capsule in adults and children from 2 years of age, or
• prior to PillCam UGI, COLON, and Crohn’s capsules in adults
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180171 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180171: PillCam Patency System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180171
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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