510(k) · Cleared
ClearedGiven Pillcam Platform with Pillcam SB Capsules
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 Mar 7, 2011 as substantially equivalent to K090557 (Given Imaging, Ltd., 2009) after a 307-day review. Its family tree reaches back 14 generations to 2001. 12 later devices descend from it.
- Decided
- Mar 7, 2011
- Review
- 307 days
- Class
- Class II
- Product code
- NEZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to DEN010002 (2001). 15 ancestors in all. 12 later devices descend from it, 1 citing it directly.
- 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 deviceK101250 Given Pillcam Platform with Pillcam SB CapsulesGiven Imaging, Ltd. · 2011
- Descendant · cites it directly · 11 of its ownK123864 Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam SB 3…Given Imaging, Ltd. · 2013
- Descendant · 2 generations on · 4 of its ownK170210 PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0Given Imaging, Ltd. · 2017
- Descendant · 2 generations on · 3 of its ownK211684 PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EGiven Imaging Ltd. (Medtronic) · 2021
- Descendant · 2 generations on · 2 of its ownK170438 MiroCam Capsule Endoscope SystemIntromedic Co., Ltd. · 2018
- Descendant · 3 generations on · 1 of its ownK230991 PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EGiven Imaging Ltd. (Medtronic) · 2023
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 deviceK101250 Given Pillcam Platform with Pillcam SB CapsulesGiven Imaging, Ltd. · 2011
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K123864Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam SB 3 Capsule Endoscopy SystemGiven Imaging, Ltd. · 2013 · cites it directly11descendants
- K170210PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0Given Imaging, Ltd. · 2017 · 2 generations on4descendants
- K211684PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EGiven Imaging Ltd. (Medtronic) · 2021 · 2 generations on3descendants
- K170438MiroCam Capsule Endoscope SystemIntromedic Co., Ltd. · 2018 · 2 generations on2descendants
- K230991PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EGiven Imaging Ltd. (Medtronic) · 2023 · 3 generations on1descendant
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) | 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 | — |
| +2 | K170210 | PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 | Given Imaging, Ltd. | 2017 | — |
| +2 | K211684 | PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E | Given Imaging Ltd. (Medtronic) | 2021 | — |
| +2 | K170438 | MiroCam Capsule Endoscope System | Intromedic Co., Ltd. | 2018 | — |
| +3 | K230991 | PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E | Given Imaging Ltd. (Medtronic) | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (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 1…- System, Imaging, Gastrointestinal, Wireless, Capsule Predicate Device(s): Given®'Diagnostic System with PilICam® S132 Capsule (K090557) General Device The Given PillCain® Platform is comprised of three main Description: subsystems;… | 2009 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123864 | Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam SB 3 Capsule Endoscopy System | 2013 | 11 |
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 10 years and passes through 1 company; a new generation was cleared every 7 months on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K123864 (Given Imaging, Ltd., 2013) has gone furthest, with 11 descendants of its own.
- 3 other devices also cite its predicate K090557.
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. 2011, 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 Platform with a PillCam SB capsules is intended for visualization of the small bowel mucosa. The PillCam Platform with PillCam SB capsules may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy. The PillCam Platform with PillCam SB capsules may be used in the visualization of lesions that may be a source of obscure bleeding (either overt or occult) not detected by…
Read the full statement (169 words)
The PillCam Platform with a PillCam SB capsules is intended for visualization of the small bowel mucosa.
The PillCam Platform with PillCam SB capsules may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy.
The PillCam Platform with PillCam SB capsules may be used in the visualization of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy.
The PillCam Platform with PillCam SB capsules may be used in the visualization of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy.
The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.
The PillCam Platform with PillCam SB capsules may be used as a tool in the detection of abnormalities of the small bowel and is intended for use in adults and children from two years of age.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101250 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101250: Given Pillcam Platform with Pillcam SB Capsules.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101250
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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