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) → FMI — Needle, Hypodermic, Single Lumen

# FMI · Needle, Hypodermic, Single Lumen

_General Hospital · 21 CFR 880.5570 · Class 2_

**Canonical URL:** https://fda-staging.innolitics.com/productcode/FMI

## Overview

- **Product Code:** FMI
- **Device Name:** Needle, Hypodermic, Single Lumen
- **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)
- **3rd-party reviewable:** yes

## 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 (20 of 695)

Showing 20 most recent of 695 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K261719](/device/K261719.md) | Promisemed X-Safety Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | Aug 25, 2026 | SESE |
| [K262427](/device/K262427.md) | Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII) | Hh Global Technology, Inc. | Aug 10, 2026 | SESE |
| [K260933](/device/K260933.md) | Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T) | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | Aug 7, 2026 | SESE |
| [K261829](/device/K261829.md) | Profoject™ Dual-Safety Pen Needles | CMT Health PTE., Ltd. | Jul 29, 2026 | SESE |
| [K260739](/device/K260739.md) | Profoject™ Pen Needles (Model A; Model B) | CMT Health PTE., Ltd. | Jul 15, 2026 | SESE |
| [K260855](/device/K260855.md) | Profoject™ Safety Pen Needles | CMT Health PTE., Ltd. | Jun 10, 2026 | SESE |
| [K254273](/device/K254273.md) | Verisafe Safety Sterile Needles (SSN) | Promisemed Hangzhou Meditech Co., Ltd. | Apr 16, 2026 | SESE |
| [K252908](/device/K252908.md) | Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle | Sandstone Medical (Suzhou), Inc. | Mar 25, 2026 | SESE |
| [K253047](/device/K253047.md) | PRESSONE™ | Nipro Medical Corporation | Mar 24, 2026 | SESE |
| [K253622](/device/K253622.md) | Safety Pen Needle | Ningbo Medsun Medical Co., Ltd. | Mar 18, 2026 | SESE |
| [K252886](/device/K252886.md) | Pen Needle | Hh Global Technology, Inc. | Jan 6, 2026 | SESE |
| [K250700](/device/K250700.md) | Pen Injector Needle 32.5 | Terumo Corporation | Nov 21, 2025 | SESE |
| [K252631](/device/K252631.md) | Profoject™ Disposable Needle | CMT Health PTE., Ltd. | Oct 16, 2025 | SESE |
| [K250724](/device/K250724.md) | Intraosseous Infusion Needles | Spectrum Vascular | Jul 30, 2025 | SESE |
| [K250284](/device/K250284.md) | TSK SELECT™ Needle | Tsk Laboratory, Japan | Jul 24, 2025 | SESE |
| [K251447](/device/K251447.md) | K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) | Terumo Europe N.V. | Jul 8, 2025 | SESE |
| [K243309](/device/K243309.md) | 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) | Terumo Europe N.V. | May 29, 2025 | SESE |
| [K240355](/device/K240355.md) | FROG  (Filter Removal of Glass) | Carrtech Corp | Apr 18, 2025 | SESE |
| [K243581](/device/K243581.md) | K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) | Terumo Europe N.V. | Apr 4, 2025 | SESE |
| [K250658](/device/K250658.md) | SureFine Pen Needle | Shina Med Corporation | Apr 3, 2025 | SESE |

## Top Applicants

- Bd Becton Dickinson Vacutainer Systems Preanalytic — 20 clearances
- Terumo Europe N.V. — 15 clearances
- Promisemed Hangzhou Meditech Co., Ltd. — 13 clearances
- Sherwood Medical Co. — 13 clearances
- Vidacare Corporation — 13 clearances

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**Source:** [https://fda-staging.innolitics.com/productcode/FMI](https://fda-staging.innolitics.com/productcode/FMI)

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