# K252480: CE Deliver (DLV)

- Pathway: 510(k) (Traditional)
- Applicant: CapsoVision, Inc.
- Decided: Dec 19, 2025 after 134 days
- Product code: NEZ (System, Imaging, Gastrointestinal, Wireless, Capsule)
- Device class: 2
- Regulation: 21 CFR 876.1300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K163495 (2017). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163495: AdvanCE capsule endoscope delivery device, United States Endoscopy Group, Inc. (2017) Summary page 5.

## Indications for use
The disposable CE Deliver is a 2.5mm single-sheathed device indicated for transendoscopic delivery to the stomach or duodenum of CapsoCam Plus capsule endoscope (CE) devices. This device is intended for patients who are either unable to swallow the capsule or unable to pass the capsule beyond the pylorus in sufficient time to complete the desired diagnostic evaluation.

Source page: https://510kreport.com/device/K252480
Methodology: https://510kreport.com/methodology