# DEN220065: Pill Sense System

- Pathway: De Novo (Direct)
- Applicant: Enterasense, Ltd.
- Decided: Feb 24, 2023 after 148 days
- Product code: QUD (Blood Detection Capsule)
- Device class: 2
- Regulation: 21 CFR 876.1390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The PillSense System is a prescription only device consisting of a reusable receiver and single-use ingestible capsule, intended to be used for the detection of blood in the upper gastrointestinal tract in hemodynamically stable adults suspected of having upper gastrointestinal bleeding (UGIB). PillSense is not a standalone diagnostic device, but an adjunct for clinical decision making. A negative or normal result obtained by PillSense System does not exclude presence of pathology, if symptoms persist, further evaluation should be performed.

Source page: https://510kreport.com/device/DEN220065
Methodology: https://510kreport.com/methodology