FDA Product Code DPT: Probe, Blood-flow, Extravascular
Leading manufacturers include Rwd Life Science Co., Ltd..
FDA 510(k) Cleared Probe, Blood-flow, Extravascular Devices (Product Code DPT)
About Product Code DPT - Regulatory Context
510(k) Submission Activity
48 total 510(k) submissions under product code DPT since 1978, with 48 receiving FDA clearance (average review time: 183 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under DPT have taken an average of 245 days to reach a decision - up from 181 days historically. Manufacturers should account for longer review timelines in current project planning.
DPT devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →