DeviceClearance

Product code KDJ— Gastroenterology, Urology

ABBOTT SMART CAP

Classification name
Set, Administration, For Peritoneal Dialysis, Disposable
Device class
Class 2
Regulation
21 CFR 876.5630
Advisory panel
Gastroenterology, Urology
Total cleared
113
First cleared
Most recent

Market context for product code KDJ

FDA has cleared 113 devices under product code KDJ between 1977 and 2025, filed by 32 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code KDJ

Adverse events under product code KDJ

product code KDJ
Death
298
Injury
9,221
Malfunction
8,438
Other
1
Total
17,958

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code KDJ

1–100 of 113

Data sourced from openFDA. This site is unofficial and independent of the FDA.