510(k) · Cleared
ClearedPillCam SB 3 capsule endoscopy system, PillCam Software 9.0E
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Given Imaging Ltd. (Medtronic) · NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
Cleared on Aug 27, 2021 as substantially equivalent to K123864 (Given Imaging, Ltd., 2013) and 1 other predicate after an 87-day review. Its family tree reaches back 17 generations to 2001. 3 later devices descend from it.
- Decided
- Aug 27, 2021
- Review
- 87 days
- Class
- Class II
- Product code
- NEZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 17 generations to DEN010002 (2001). 23 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 17 generations backDEN010002 Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2001
- 13 generations between
- 3 generations backK101250 Given Pillcam Platform with Pillcam SB CapsulesGiven Imaging, Ltd. · 2011
- 2 generations backK123864 Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam SB 3…Given Imaging, Ltd. · 2013
- 1 generation backK170210 PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0Given Imaging, Ltd. · 2017
- This deviceK211684 PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EGiven Imaging Ltd. (Medtronic) · 2021
- Descendant · cites it directly · 1 of its ownK230991 PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EGiven Imaging Ltd. (Medtronic) · 2023
- Descendant · cites it directly · 0 of its ownK242643 CapsoCam Plus (SV-3) Capsule Endoscopy SystemCapsoVision, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK240276 PillCam™ Genius SB System with PillCam Software v9.7 and PillCam…Given Imaging Ltd. (D.B.A. Medtronic) · 2024
Show all 17 generations
- Root · 17 generations backDEN010002 Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2001
- 16 generations backK020341 Given Diagnostic SystemGiven Imaging, Ltd. · 2002
- 15 generations backK022362 Given Diagnostics SystemGiven Imaging, Ltd. · 2002
- 14 generations backK022980 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 13 generations backK031033 Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 12 generations backK032405 Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 11 generations backK040248 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2004
- 10 generations backK041149 Given Diagnostic System with M2A Eso CapsuleGiven Imaging, Ltd. · 2004
- 9 generations backK042960 Given Diagnostic System with Pillcam EsoGiven Imaging, Ltd. · 2004
- 8 generations backK052184 Given Diagnostic SystemGiven Imaging, Ltd. · 2005
- 7 generations backK060805 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2006
- 6 generations backK062786 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2006
- 5 generations backK070475 Modificaton to: Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2007
- 4 generations backK090557 Given Pillcam Platform Will Pillcam SB Capsules, Eso Capsules, Given…Given Imaging, Ltd. · 2009
- 3 generations backK101250 Given Pillcam Platform with Pillcam SB CapsulesGiven Imaging, Ltd. · 2011
- 2 generations backK123864 Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam SB 3…Given Imaging, Ltd. · 2013
- 1 generation backK170210 PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0Given Imaging, Ltd. · 2017
- This deviceK211684 PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EGiven Imaging Ltd. (Medtronic) · 2021
Most influential descendants
Showing 3 of 3 · See all- K230991PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EGiven Imaging Ltd. (Medtronic) · 2023 · cites it directly1descendant
- K242643CapsoCam Plus (SV-3) Capsule Endoscopy SystemCapsoVision, Inc. · 2024 · cites it directly0descendants
- K240276PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader SoftwareGiven Imaging Ltd. (D.B.A. Medtronic) · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | DEN010002 | Given Diagnostic Imaging System | Given Imaging, Ltd. | 2001 | — |
| −16 | K020341 | Given Diagnostic System | Given Imaging, Ltd. | 2002 | — |
| −15 | K022362 | Given Diagnostics System | Given Imaging, Ltd. | 2002 | — |
| −14 | K022980 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −13 | K031033 | Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −12 | K032405 | Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −11 | K040248 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2004 | — |
| −10 | K041149 | Given Diagnostic System with M2A Eso Capsule | Given Imaging, Ltd. | 2004 | — |
| −9 | K042960 | Given Diagnostic System with Pillcam Eso | Given Imaging, Ltd. | 2004 | — |
| −8 | K052184 | Given Diagnostic System | Given Imaging, Ltd. | 2005 | — |
| −7 | K060805 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2006 | — |
| −6 | K062786 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2006 | — |
| −5 | K070475 | Modificaton to: Given Diagnostic Imaging System | Given Imaging, Ltd. | 2007 | — |
| −4 | K090557 | Given Pillcam Platform Will Pillcam SB Capsules, Eso Capsules, Given Agile… | Given Imaging, Ltd. | 2009 | — |
| −3 | K101250 | Given Pillcam Platform with Pillcam SB Capsules | Given Imaging, Ltd. | 2011 | — |
| −2 | K123864 | Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam SB 3 Capsule… | Given Imaging, Ltd. | 2013 | — |
| −1 | K170210 | PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 | Given Imaging, Ltd. | 2017 | — |
| 0 (this device) | K211684 | PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E | Given Imaging Ltd. (Medtronic) | 2021 | — |
| +1 | K230991 | PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E | Given Imaging Ltd. (Medtronic) | 2023 | — |
| +1 | K242643 | CapsoCam Plus (SV-3) Capsule Endoscopy System | CapsoVision, Inc. | 2024 | — |
| +2 | K240276 | PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader… | Given Imaging Ltd. (D.B.A. Medtronic) | 2024 | — |
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 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K123864 | Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam SB 3 Capsule Endoscopy SystemSummary page 4…CFR 876.1300 Product Code: NEZ Predicate Devices Given PillCam SB 3 capsule endoscopy system and Given PillCam® endoscopy system with RAPID 8.0 (K123864) – Primary Predicate Given Imaging PillCam SBC capsule endoscopy system and PillCam Desktop Software 9.0 (K170210)… | 2013 |
| * | K170210 | PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0Summary page 4…endoscopy system with RAPID 8.0 (K123864) – Primary Predicate Given Imaging PillCam SBC capsule endoscopy system and PillCam Desktop Software 9.0 (K170210) – Secondary Predicate 53… | 2017 |
What descends from it? (3)
2 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 20 years and passes through 2 companies; a new generation was cleared every 7 months on median.
- None of the 23 ancestors has a recall.
- Of its descendants, K230991 (Given Imaging Ltd. (Medtronic), 2023) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K123864.
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. 2021, 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 SB 3 capsule is intended for visualization of the small bowel mucosa. It may be used in the visualization and monitoring of lesions that may indicate Crohn’s disease not detected by upper and lower endoscopy. It may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy. It may be used in the visualization and monitoring of lesions that…
Read the full statement (150 words)
The PillCam SB 3 capsule is intended for visualization of the small bowel mucosa.
It may be used in the visualization and monitoring of lesions that may indicate Crohn’s disease not detected by upper and lower endoscopy.
It may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy.
It may be used in the visualization and monitoring 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 SB 3 capsule 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/K211684 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211684: PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211684
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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