De Novo · Granted
GrantedPill Sense System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Enterasense, Ltd. · QUD Blood Detection Capsule
Granted on Feb 24, 2023 as a new device type through De Novo after a 148-day review.
- Decided
- Feb 24, 2023
- Review
- 148 days
- Class
- Class II
- Product code
- QUD
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo 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 QUD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All QUD devicesQUD Blood Detection Capsule: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QUD
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QUD
Too few QUD 510(k)s in any year since 2007 to give a median.
Recalls per year · QUD
No recall names QUD since 2007.
Adverse event reports per year · QUD
No MAUDE report names QUD since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN220065 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN220065: Pill Sense System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN220065
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026