510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN220065Unknown

Pill Sense System

Enterasense Limited, Galway, IE / Direct, Unknown
FDA source (opens on fda.gov)

DEN220065 is the FDA 510(k) clearance record for Pill Sense System, a class II device, cleared for Enterasense , Ltd. on under FDA product code QUD (Blood Detection Capsule). FDA's definition for product code QUD reads: "Ingestible gastrointestinal blood detection capsule device is a prescription device that uses spectrophotometry (light absorption technology) to detect the presence or absence of blood in the gastrointestinal tract". FDA records list one 510(k) clearance for Enterasense , Ltd. As of , FDA records show no recalls naming DEN220065.

Clearance record

Decision date
Received
(148 days to decision)
Product code
QUD Blood Detection Capsule
Regulation
21 CFR 876.1390
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Enterasense , Ltd. Unit 3 Ballybrit Business Park, Mervue, Galway, IE
Third party review
No

Clearances, product code QUD

Trailing 12 months

FDA records hold no clearances under product code QUD in the trailing twelve months.

FDA records show no clearances under product code QUD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QUD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260