# K183192: CapsoCam Plus (SV-3)

- Pathway: 510(k) (Special)
- Applicant: CapsoVision, Inc.
- Decided: Apr 19, 2019 after 151 days
- Product code: NEZ (System, Imaging, Gastrointestinal, Wireless, Capsule)
- Device class: 2
- Regulation: 21 CFR 876.1300
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K192662: CapsoCam Plus (SV-3) Capsule Endoscopy System (2020), 1 descendant of its own
- K242643: CapsoCam Plus (SV-3) Capsule Endoscopy System (2024), 0 descendants of its own

## Recalls of this device
- Oct 18, 2019 · Class II · Z-1827-2020: 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
- Jul 3, 2019 · Class II · Z-2073-2020: Possible mis-labeling of the device with incorrect serial number labels which may result in a patient's misdiagnosis.

Source page: https://510kreport.com/device/K183192
Methodology: https://510kreport.com/methodology