Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5570](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5570) → PTI — Non-Coring (Huber) Needle

# PTI · Non-Coring (Huber) Needle

_General Hospital · 21 CFR 880.5570 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PTI

## Overview

- **Product Code:** PTI
- **Device Name:** Non-Coring (Huber) Needle
- **Regulation:** [21 CFR 880.5570](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5570)
- **Device Class:** 2
- **Review Panel:** [General Hospital](/submissions/HO)

## 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](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PTI/K252355.md) | K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing | Sb-Kawasumi Laboratories, Inc. | Nov 26, 2025 | SESE |
| [K251138](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PTI/K251138.md) | Promisemed Safety Huber Needles | Promisemed Hangzhou Meditech Co., Ltd. | May 13, 2025 | SESE |
| [K243332](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PTI/K243332.md) | Promisemed Safety Huber Needles | Promisemed Hangzhou Meditech Co., Ltd. | Mar 14, 2025 | SESE |
| [K241353](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PTI/K241353.md) | PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set | Bard Access Systems, Inc. | Nov 27, 2024 | SESE |
| [K230715](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PTI/K230715.md) | Promisemed Safety Huber Needle | Promisemed Hangzhou Meditech Co., Ltd. | Jun 8, 2023 | SESE |
| [K213823](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PTI/K213823.md) | Intera Refill Kit | Intera Oncology, Inc. | Mar 16, 2022 | SESE |
| [K211121](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PTI/K211121.md) | 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](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PTI/K200463.md) | Huber Needle Infusion Set, Safety Huber Needle Infusion Set | Jiangsu Caina Medical Co.,Ltd | Apr 7, 2021 | SESE |
| [K170881](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PTI/K170881.md) | ISP Safety Huber Needle Infusion Set | Infusion Safety Products, Inc. | Dec 14, 2017 | SESE |
| [K170897](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PTI/K170897.md) | 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](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PTI/K171735.md) | PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set | C.R. Bard, Inc. | Aug 8, 2017 | SESE |
| [K171333](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PTI/K171333.md) | 20G x 5/8 Pro-Lock CT Safety Infusion Set | Medcomp (Dba Medical Components, Inc.) | Jul 18, 2017 | SESE |
| [K162271](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PTI/K162271.md) | 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

---

**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PTI](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PTI)

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