DeviceClearance

Product code KPY— Radiology

2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4)

Classification name
Shield, Protective, Personnel
Device class
Class 1
Regulation
21 CFR 892.6500
Advisory panel
Radiology
Total cleared
25
First cleared
Most recent

Market context for product code KPY

FDA has cleared 25 devices under product code KPY between 1978 and 2011, filed by 18 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code KPY

Recent clearances under product code KPY

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