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., Intera Oncology, Inc. and Medcomp (Medical Components, Inc.).
13
Total
13
Cleared
164d
Avg days
2017
Since
Growing category -
4 submissions in the last 2 years
vs 1 in the prior period
Review times improving: avg
122d
recently vs 183d historically
FDA 510(k) Cleared Non-coring (huber) Needle Devices (Product Code PTI)
13 devices
Cleared
Nov 26, 2025
K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing
Sb-Kawasumi Laboratories, Inc.
General Hospital
120d
Cleared
May 13, 2025
Promisemed Safety Huber Needles
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital
29d
Cleared
Mar 14, 2025
Promisemed Safety Huber Needles
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital
141d
Cleared
Nov 27, 2024
PowerLoc™ Max Power Injectable Infusion Set
Bard Access Systems, Inc.
General Hospital
198d
Cleared
Jun 08, 2023
Promisemed Safety Huber Needle
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital
85d
Cleared
Mar 16, 2022
Intera Refill Kit
Intera Oncology, Inc.
General Hospital
98d
Cleared
Oct 14, 2021
Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit
Intera Oncology, Inc.
General Hospital
182d
Cleared
Apr 07, 2021
Huber Needle Infusion Set, Safety Huber Needle Infusion Set
Jiangsu Caina Medical Co.,Ltd
General Hospital
407d
Cleared
Dec 14, 2017
ISP Safety Huber Needle Infusion Set
Infusion Safety Products, Inc.
General Hospital
265d
Cleared
Nov 03, 2017
Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site
B.Braun Medical, Inc.
General Hospital
221d
Cleared
Aug 08, 2017
PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set
C.R. Bard, Inc.
General Hospital
57d
Cleared
Jul 18, 2017
20G x 5/8 Pro-Lock CT Safety Infusion Set
Medcomp (Dba Medical Components, Inc.)
General Hospital
71d
Cleared
Apr 26, 2017
Pro-Lock CT Safety Infusion Set
Medcomp (Medical Components, Inc.)
General Hospital
257d
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 510(k) Review Time - PTI Product Code
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 →