FDA Product Code KPJ: Chamber, Oxygen, Topical, Extremity
Leading manufacturers include Vaporox, Inc..
FDA 510(k) Cleared Chamber, Oxygen, Topical, Extremity Devices (Product Code KPJ)
About Product Code KPJ - Regulatory Context
510(k) Submission Activity
23 total 510(k) submissions under product code KPJ since 1983, with 23 receiving FDA clearance (average review time: 199 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under KPJ have taken an average of 47 days to reach a decision - down from 206 days historically, suggesting improved FDA processing for this classification.
KPJ devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →