FDA Product Code PTI: Non-coring (huber) Needle
FDA product code PTI covers non-coring Huber needles used to access implanted subcutaneous ports.
These specialized needles have a deflected tip that pierces the silicone port membrane without coring out material, allowing repeated access to implanted venous access ports for chemotherapy, parenteral nutrition, and blood sampling without damaging the port septum.
PTI devices are Class II medical devices, regulated under 21 CFR 880.5570 and reviewed by the FDA General Hospital panel.
Leading manufacturers include Promisemed Hangzhou Meditech Co., Ltd., Jiangsu Caina Medical Co.,Ltd and Bard Access Systems, Inc..
FDA 510(k) Cleared Non-coring (huber) Needle Devices (Product Code PTI)
About Product Code PTI - Regulatory Context
510(k) Submission Activity
13 total 510(k) submissions under product code PTI since 2017, with 13 receiving FDA clearance (average review time: 164 days).
Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under PTI have taken an average of 122 days to reach a decision - down from 183 days historically, suggesting improved FDA processing for this classification.
PTI devices are reviewed by the General Hospital panel. Browse all General Hospital devices →