510(k) · Cleared
ClearedCapsoCam (SV-1)
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 Feb 9, 2016 as substantially equivalent to K070475 (Given Imaging, Ltd., 2007) after a 237-day review. Its family tree reaches back 13 generations to 2001. 1 later device descends from it.
- Decided
- Feb 9, 2016
- Review
- 237 days
- Class
- Class II
- Product code
- NEZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to DEN010002 (2001). 1 later device descends from it, 1 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 deviceK151635 CapsoCam (SV-1)CapsoVision, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK161773 CapsoCam Plus (SV-3) Capsule Endoscope SystemCapsoVision, Inc. · 2016
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 deviceK151635 CapsoCam (SV-1)CapsoVision, Inc. · 2016
Most influential descendants
Showing 1 of 1 · See all- K161773CapsoCam Plus (SV-3) Capsule Endoscope SystemCapsoVision, Inc. · 2016 · cites it directly0descendants
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) | K151635 | CapsoCam (SV-1) | CapsoVision, Inc. | 2016 | — |
| +1 | K161773 | CapsoCam Plus (SV-3) Capsule Endoscope System | CapsoVision, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 |
|---|---|---|---|
| * | K070475 | Modificaton to: Given Diagnostic Imaging SystemSummary page 4…etric gastrointestinal capsule imaging system (21 CFR § 876.1300) Predicate Devices: Given Imaging PillCam™ SB2 (K070475) Intended Use: The CapsoCam video capsule system is intended for visualization of the small bowel mucosa in adul… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161773 | CapsoCam Plus (SV-3) Capsule Endoscope System | 2016 | 0 |
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 15 years and passes through 2 companies; a new generation was cleared every 6 months on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K161773 (CapsoVision, Inc., 2016) has gone furthest, with 0 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. 2016, 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 SV-1 video capsule system is intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151635 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151635: CapsoCam (SV-1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151635
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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