510(k) · Cleared
ClearedCapsoCam Plus (SV-3) Capsule Endoscopy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CapsoVision, Inc. · NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
Cleared on Dec 4, 2024 as substantially equivalent to K192662 (CapsoVision, Inc., 2020) and 1 other predicate after a 92-day review. Its family tree reaches back 18 generations to 2001.
- Decided
- Dec 4, 2024
- Review
- 92 days
- Class
- Class II
- Product code
- NEZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 18 generations to DEN010002 (2001). 26 ancestors in all. No later device cites it as a predicate yet.
- Root · 18 generations backDEN010002 Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2001
- 14 generations between
- 3 generations backK123864 Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam SB 3…Given Imaging, Ltd. · 2013
- 2 generations backK170210 PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0Given Imaging, Ltd. · 2017
- 1 generation backK211684 PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EGiven Imaging Ltd. (Medtronic) · 2021
- This deviceK242643 CapsoCam Plus (SV-3) Capsule Endoscopy SystemCapsoVision, Inc. · 2024
Show all 18 generations
- Root · 18 generations backDEN010002 Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2001
- 17 generations backK020341 Given Diagnostic SystemGiven Imaging, Ltd. · 2002
- 16 generations backK022362 Given Diagnostics SystemGiven Imaging, Ltd. · 2002
- 15 generations backK022980 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 14 generations backK031033 Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 13 generations backK032405 Given Diagnostic SystemGiven Imaging, Ltd. · 2003
- 12 generations backK040248 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2004
- 11 generations backK041149 Given Diagnostic System with M2A Eso CapsuleGiven Imaging, Ltd. · 2004
- 10 generations backK042960 Given Diagnostic System with Pillcam EsoGiven Imaging, Ltd. · 2004
- 9 generations backK052184 Given Diagnostic SystemGiven Imaging, Ltd. · 2005
- 8 generations backK060805 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2006
- 7 generations backK062786 Modification to Given Diagnostic SystemGiven Imaging, Ltd. · 2006
- 6 generations backK070475 Modificaton to: Given Diagnostic Imaging SystemGiven Imaging, Ltd. · 2007
- 5 generations backK090557 Given Pillcam Platform Will Pillcam SB Capsules, Eso Capsules, Given…Given Imaging, Ltd. · 2009
- 4 generations backK101250 Given Pillcam Platform with Pillcam SB CapsulesGiven Imaging, Ltd. · 2011
- 3 generations backK123864 Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam SB 3…Given Imaging, Ltd. · 2013
- 2 generations backK170210 PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0Given Imaging, Ltd. · 2017
- 1 generation backK211684 PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EGiven Imaging Ltd. (Medtronic) · 2021
- This deviceK242643 CapsoCam Plus (SV-3) Capsule Endoscopy SystemCapsoVision, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | DEN010002 | Given Diagnostic Imaging System | Given Imaging, Ltd. | 2001 | — |
| −17 | K020341 | Given Diagnostic System | Given Imaging, Ltd. | 2002 | — |
| −16 | K022362 | Given Diagnostics System | Given Imaging, Ltd. | 2002 | — |
| −15 | K022980 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −14 | K031033 | Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −13 | K032405 | Given Diagnostic System | Given Imaging, Ltd. | 2003 | — |
| −12 | K040248 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2004 | — |
| −11 | K041149 | Given Diagnostic System with M2A Eso Capsule | Given Imaging, Ltd. | 2004 | — |
| −10 | K042960 | Given Diagnostic System with Pillcam Eso | Given Imaging, Ltd. | 2004 | — |
| −9 | K052184 | Given Diagnostic System | Given Imaging, Ltd. | 2005 | — |
| −8 | K060805 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2006 | — |
| −7 | K062786 | Modification to Given Diagnostic System | Given Imaging, Ltd. | 2006 | — |
| −6 | K070475 | Modificaton to: Given Diagnostic Imaging System | Given Imaging, Ltd. | 2007 | — |
| −5 | K090557 | Given Pillcam Platform Will Pillcam SB Capsules, Eso Capsules, Given Agile… | Given Imaging, Ltd. | 2009 | — |
| −4 | K101250 | Given Pillcam Platform with Pillcam SB Capsules | Given Imaging, Ltd. | 2011 | — |
| −3 | 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 | — |
| −1 | K211684 | PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E | Given Imaging Ltd. (Medtronic) | 2021 | — |
| 0 (this device) | K242643 | CapsoCam Plus (SV-3) Capsule Endoscopy System | CapsoVision, Inc. | 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 |
| 2019 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K192662 | CapsoCam Plus (SV-3) Capsule Endoscopy SystemSummary page 5…876.1300 Product Code(s) NEZ | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K192662 CapsoVision, Inc., CapsoCam Plus (SV-3) Capsule Endoscopy g| | NEZ K211684 Given Imaging Ltd. (Medtronic) PillCam SB3 Capsule End… | 2020 |
| * | K211684 | PillCam SB 3 capsule endoscopy system, PillCam Software 9.0ESummary page 5…807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K192662 CapsoVision, Inc., CapsoCam Plus (SV-3) Capsule Endoscopy g| | NEZ K211684 Given Imaging Ltd. (Medtronic) PillCam SB3 Capsule Endoscopy| | NEZ Device Description Summary 21 CFR 807.92(a)(4) The CapsoCam… | 2021 |
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 23 years and passes through 3 companies; a new generation was cleared every 8 months on median.
- 2 of the 26 ancestors have a recall of any class.
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. 2024, 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 CapsoCam Plus SV-3 capsule endoscopy system is intended for visualization of the small bowel mucosa in adults and children older than two years of age. It may be used as a tool in the detection of abnormalities of the small bowel.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K242643 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242643: CapsoCam Plus (SV-3) Capsule Endoscopy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242643
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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