PTIClass II

Non-Coring (Huber) Needle

21 CFR 880.5570 / General Hospital

PTI is the FDA product code for Non-Coring (Huber) Needle, a class II device type, regulated under 21 CFR 880.5570. FDA's definition for this code reads: "The non-coring needle (Huber) is utilized to gain access into a subcutaneous implanted intravascular infusion port but can also be used to access other non-vascular implanted devices with similar septums". As of 2026-09-10, FDA records hold 13 510(k) clearances under this code, the most recent dated 2025-11-26, and 12 recalls.

Classification record

Product code: PTI
Device name: Non-Coring (Huber) Needle
FDA definition: The non-coring needle (Huber) is utilized to gain access into a subcutaneous implanted intravascular infusion port but can also be used to access other non-vascular implanted devices with similar septums.
Regulation: 21 CFR 880.5570
Device class: Class II
Review panel: General Hospital
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 14
Ingested recalls: 12

Clearances, product code PTI

By decision year

14 clearances under product code PTI with a decision year between 2017 and 2026, 2017 the highest year at 5.

Show the numbers

510(k) clearances under FDA product code PTI by decision year
Year	Clearances
2017	5
2021	2
2022	1
2023	1
2024	1
2025	3
2026	1

Applicants with the most clearances

Product code PTI

Applicants holding the most 510(k) clearances under product code PTI
Applicant	Clearances
Promisemed Hangzhou Meditech Co.,Ltd.	3
Intera Oncology	2
B.Braun Medical, Inc.	1
Bard Access Systems, Inc.	1
C.R. Bard Inc	1
Infusion Safety Products, Inc.	1
Jiangsu Caina Medical Co., Ltd	1
Martech Medical Products	1
Medcomp (dba Medical Components, Inc.)	1
Medcomp ( Medical Components)	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 29 companies shown, in name order