DeviceClearance

Product code IKY— General Hospital

BEDDING PADS EGGCREATE PADS

Classification name
Mattress, Flotation Therapy, Non-Powered
Device class
Class 1
Regulation
21 CFR 880.5150
Advisory panel
General Hospital
Total cleared
8
First cleared
Most recent

Market context for product code IKY

FDA has cleared 8 devices under product code IKY between 1976 and 1992, filed by 6 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 IKY

Adverse events under product code IKY

product code IKY
Death
5
Malfunction
491
Other
4
Total
500

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 IKY

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