FMI · Needle, Hypodermic, Single Lumen
General Hospital · 21 CFR 880.5570 · Class 2
Overview
| Product Code | FMI |
|---|---|
| Device Name | Needle, Hypodermic, Single Lumen |
| Regulation | 21 CFR 880.5570 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 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 689)
Showing 20 most recent of 689 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K254273 | Verisafe Safety Sterile Needles (SSN) | Promisemed Hangzhou Meditech Co., Ltd. | Apr 16, 2026 | SESE |
| K252908 | 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 | PRESSONE | Nipro Medical Corporation | Mar 24, 2026 | SESE |
| K253622 | Safety Pen Needle | Ningbo Medsun Medical Co., Ltd. | Mar 18, 2026 | SESE |
| K252886 | Pen Needle | Hh Global Technology, Inc. | Jan 6, 2026 | SESE |
| K250700 | Pen Injector Needle 32.5 | Terumo Corporation | Nov 21, 2025 | SESE |
| K252631 | Profoject Disposable Needle | CMT Health PTE., Ltd. | Oct 16, 2025 | SESE |
| K250724 | Intraosseous Infusion Needles | Spectrum Vascular | Jul 30, 2025 | SESE |
| K250284 | TSK SELECT Needle | Tsk Laboratory, Japan | Jul 24, 2025 | SESE |
| K251447 | K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) | Terumo Europe N.V. | Jul 8, 2025 | SESE |
| K243309 | 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) | Terumo Europe N.V. | May 29, 2025 | SESE |
| K240355 | FROG (Filter Removal of Glass) | Carrtech Corp | Apr 18, 2025 | SESE |
| K243581 | K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) | Terumo Europe N.V. | Apr 4, 2025 | SESE |
| K250658 | SureFine Pen Needle | Shina Med Corporation | Apr 3, 2025 | SESE |
| K243806 | Safety Winged Blood Collection Sets | Promisemed Hangzhou Meditech Co., Ltd. | Jan 10, 2025 | SESE |
| K242741 | ACE Cannula | Ace Medical Industry Co., Ltd. | Jan 8, 2025 | SESE |
| K242632 | Verifine® Pen Needles | Promisemed Hangzhou Meditech Co., Ltd. | Sep 26, 2024 | SESE |
| K240915 | ZIEN IO Intraosseous Access System | Zien Medical Technologies, Inc. | Jul 2, 2024 | SESE |
| K232165 | Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles | Berpu Medical Technology Co., Ltd. | Feb 1, 2024 | SESE |
| K233037 | Sterile Hypodermic Needles for Single Use | Zhejiang Kindly Medical Device Co., Ltd. | Dec 12, 2023 | SESE |
Top Applicants
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 20 clearances
- Terumo Europe N.V. — 15 clearances
- Sherwood Medical Co. — 13 clearances
- Vidacare Corporation — 13 clearances
- Promisemed Hangzhou Meditech Co., Ltd. — 12 clearances
