510(k) · Cleared
ClearedPillcam Platform with Pillcam SB Capsules with Pillcam Sensorbelt
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 Jul 29, 2009 as substantially equivalent to K070475 (Given Imaging, Ltd., 2007) and 1 other predicate after a 78-day review. Its family tree reaches back 13 generations to 2001. 17 later devices descend from it.
- Decided
- Jul 29, 2009
- Review
- 78 days
- Class
- Class II
- Product code
- NEZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to DEN010002 (2001). 17 later devices descend from it, 2 citing it directly.
- Root · 13 generations backDEN010002 Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2001
- 9 generations between
- 3 generations backK060805 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2006
- 2 generations backK062786 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2006
- 1 generation backK070475 Modificaton to: Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2007
- This deviceK091405 Pillcam Platform with Pillcam SB Capsules with Pillcam SensorbeltGiven Imaging, Ltd. · 2009
- 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 · cites it directly · 6 of its ownK103088 Given Pillcam Platform with Pillcam SB Capsuleswith Pillcam R…Given Imaging, Ltd. · 2011
- Descendant · 2 generations on · 5 of its ownK140751 Mirocam Capsule Endoscope SystemIntromedic Co., Ltd. · 2014
- Descendant · 3 generations on · 4 of its ownK170210 PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0Given Imaging, Ltd. · 2017
Show all 13 generations
- Root · 13 generations backDEN010002 Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2001
- 12 generations backK020341 Given Diagnostic SystemGiven Imaging, Ltd. · 2002
- 11 generations backK022362 Given Diagnostics SystemGiven Imaging, Ltd. · 2002
- 10 generations backK022980 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 9 generations backK031033 Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 8 generations backK032405 Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 7 generations backK040248 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2004
- 6 generations backK041149 Given Diagnostic System with M2A Eso CapsuleGiven Imaging, Ltd. · 2004
- 5 generations backK042960 Given Diagnostic System with Pillcam EsoGiven Imaging, Ltd. · 2004
- 4 generations backK052184 Given Diagnostic SystemGiven Imaging, Ltd. · 2005
- 3 generations backK060805 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2006
- 2 generations backK062786 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2006
- 1 generation backK070475 Modificaton to: Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2007
- This deviceK091405 Pillcam Platform with Pillcam SB Capsules with Pillcam SensorbeltGiven Imaging, Ltd. · 2009
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · 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
- K103088Given Pillcam Platform with Pillcam SB Capsuleswith Pillcam R SensorbeltGiven Imaging, Ltd. · 2011 · cites it directly6descendants
- K140751Mirocam Capsule Endoscope SystemIntromedic Co., Ltd. · 2014 · 2 generations on5descendants
- K170210PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0Given Imaging, Ltd. · 2017 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | DEN010002 | Given Diagnostic Imaging System | Given Imaging, Ltd. | 2001 | — |
| −12 | K020341 | Given Diagnostic System | Given Imaging, Ltd. | 2002 | — |
| −11 | K022362 | Given Diagnostics System | Given Imaging, Ltd. | 2002 | — |
| −10 | K022980 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −9 | K031033 | Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −8 | K032405 | Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −7 | K040248 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2004 | — |
| −6 | K041149 | Given Diagnostic System with M2A Eso Capsule | Given Imaging, Ltd. | 2004 | — |
| −5 | K042960 | Given Diagnostic System with Pillcam Eso | Given Imaging, Ltd. | 2004 | — |
| −4 | K052184 | Given Diagnostic System | Given Imaging, Ltd. | 2005 | — |
| −3 | K060805 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2006 | — |
| −2 | K062786 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2006 | — |
| −1 | K070475 | Modificaton to: Given Diagnostic Imaging System | Given Imaging, Ltd. | 2007 | — |
| 0 (this device) | K091405 | Pillcam Platform with Pillcam SB Capsules with Pillcam Sensorbelt | Given Imaging, Ltd. | 2009 | — |
| +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 | — |
| +1 | K103088 | Given Pillcam Platform with Pillcam SB Capsuleswith Pillcam R Sensorbelt | Given Imaging, Ltd. | 2011 | — |
| +2 | K140751 | Mirocam Capsule Endoscope System | Intromedic Co., Ltd. | 2014 | — |
| +3 | K170210 | PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 | Given Imaging, Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 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 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? (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 |
|---|---|---|---|
| * | K070475 | Modificaton to: Given Diagnostic Imaging SystemSummary page 1…, Imaging, Gastrointestinal, Wireless, Capsule Predicate Device(s): Given® Diagnostic System with PillCam® SB2 Capsule (K070475) Given® Diagnostic System (K062786) Given Imaging Ltd. New Industrial Park, PO Bo… | 2007 |
| * | K062786 | Modification to Given Diagnostic SystemSummary page 1…(s): Given® Diagnostic System with PillCam® SB2 Capsule (K070475) Given® Diagnostic System (K062786) Given Imaging Ltd. New Industrial Park, PO Box 258, Yoqneam 20692, Israel… | 2006 |
What descends from it? (17)
See all 172 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 8 years and passes through 1 company; a new generation was cleared every 6 months on median.
- None of the 13 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 K070475.
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. 2009, 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 Given PillCam® Platform with the PillCam® SB Capsules is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults and children from 10 years of age and up.
The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091405 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091405: Pillcam Platform with Pillcam SB Capsules with Pillcam Sensorbelt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091405
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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