PTI · Non-Coring (Huber) Needle
General Hospital · 21 CFR 880.5570 · Class 2
Overview
| Product Code | PTI |
|---|---|
| Device Name | Non-Coring (Huber) Needle |
| Regulation | 21 CFR 880.5570 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252355 | K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing | Sb-Kawasumi Laboratories, Inc. | Nov 26, 2025 | SESE |
| K251138 | Promisemed Safety Huber Needles | Promisemed Hangzhou Meditech Co., Ltd. | May 13, 2025 | SESE |
| K243332 | Promisemed Safety Huber Needles | Promisemed Hangzhou Meditech Co., Ltd. | Mar 14, 2025 | SESE |
| K241353 | PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set | Bard Access Systems, Inc. | Nov 27, 2024 | SESE |
| K230715 | Promisemed Safety Huber Needle | Promisemed Hangzhou Meditech Co., Ltd. | Jun 8, 2023 | SESE |
| K213823 | Intera Refill Kit | Intera Oncology, Inc. | Mar 16, 2022 | SESE |
| K211121 | Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit | Intera Oncology, Inc. | Oct 14, 2021 | SESE |
| K200463 | Huber Needle Infusion Set, Safety Huber Needle Infusion Set | Jiangsu Caina Medical Co.,Ltd | Apr 7, 2021 | SESE |
| K170881 | ISP Safety Huber Needle Infusion Set | Infusion Safety Products, Inc. | Dec 14, 2017 | SESE |
| K170897 | Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site | B.Braun Medical, Inc. | Nov 3, 2017 | SESE |
| K171735 | PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set | C.R. Bard, Inc. | Aug 8, 2017 | SESE |
| K171333 | 20G x 5/8 Pro-Lock CT Safety Infusion Set | Medcomp (Dba Medical Components, Inc.) | Jul 18, 2017 | SESE |
| K162271 | Pro-Lock CT Safety Infusion Set | Medcomp (Medical Components, Inc.) | Apr 26, 2017 | SESE |
Top Applicants
- Promisemed Hangzhou Meditech Co., Ltd. — 3 clearances
- Intera Oncology, Inc. — 2 clearances
- B.Braun Medical, Inc. — 1 clearance
- Bard Access Systems, Inc. — 1 clearance
- C.R. Bard, Inc. — 1 clearance
