DeviceClearance

Product code KPR— Radiology

GC85A

Classification name
System, X-Ray, Stationary
Device class
Class 2
Regulation
21 CFR 892.1680
Advisory panel
Radiology
Total cleared
359
First cleared
Most recent

Market context for product code KPR

FDA has cleared 359 devices under product code KPR between 1976 and 2026, filed by 162 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 KPR

Adverse events under product code KPR

product code KPR
Other
6
Total
6

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 KPR

1–100 of 359

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