510(k) · Cleared
Recalled · Class II · 2019CapsoCam Plus (SV-3)
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 Apr 19, 2019 after a 151-day review. The FDA summary names no predicate by number. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 19, 2019
- Review
- 151 days
- Class
- Class II
- Product code
- NEZ
- Recalls
- 2
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK183192 CapsoCam Plus (SV-3)CapsoVision, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK192662 CapsoCam Plus (SV-3) Capsule Endoscopy SystemCapsoVision, Inc. · 2020 · Recalled
- Descendant · 2 generations on · 0 of its ownK242643 CapsoCam Plus (SV-3) Capsule Endoscopy SystemCapsoVision, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K183192 | CapsoCam Plus (SV-3) | CapsoVision, Inc. | 2019 | — |
| +1 | K192662 | CapsoCam Plus (SV-3) Capsule Endoscopy System | CapsoVision, Inc. | 2020 | 1 |
| +2 | K242643 | CapsoCam Plus (SV-3) Capsule Endoscopy System | CapsoVision, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2024 | 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?
The FDA summary names no predicate by number.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192662 | CapsoCam Plus (SV-3) Capsule Endoscopy System | 2020 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 18, 2019 | Class II | Z-1827-2020 | Other | Capsule Endoscopy System: a defect present in the capsule window may be stressed through the production process and in the final package, which could cause the housing of the capsule to crack and leak when ingested. Fluid from the patient… |
| Jul 3, 2019 | Class II | Z-2073-2020 | Process control | Possible mis-labeling of the device with incorrect serial number labels which may result in a patient's misdiagnosis. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K192662 (CapsoVision, Inc., 2020) has gone furthest, with 1 descendant of its own.
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. 2019, 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 | — |
https://510kreport.com/device/K183192 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183192: CapsoCam Plus (SV-3).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183192
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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