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.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/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 689) Showing 20 most recent of 689 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K254273](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K254273.md) | Verisafe Safety Sterile Needles (SSN) | Promisemed Hangzhou Meditech Co., Ltd. | Apr 16, 2026 | SESE | | [K252908](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/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](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K253047.md) | PRESSONE™ | Nipro Medical Corporation | Mar 24, 2026 | SESE | | [K253622](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K253622.md) | Safety Pen Needle | Ningbo Medsun Medical Co., Ltd. | Mar 18, 2026 | SESE | | [K252886](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K252886.md) | Pen Needle | Hh Global Technology, Inc. | Jan 6, 2026 | SESE | | [K250700](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K250700.md) | Pen Injector Needle 32.5 | Terumo Corporation | Nov 21, 2025 | SESE | | [K252631](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K252631.md) | Profoject™ Disposable Needle | CMT Health PTE., Ltd. | Oct 16, 2025 | SESE | | [K250724](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K250724.md) | Intraosseous Infusion Needles | Spectrum Vascular | Jul 30, 2025 | SESE | | [K250284](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K250284.md) | TSK SELECT™ Needle | Tsk Laboratory, Japan | Jul 24, 2025 | SESE | | [K251447](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K251447.md) | K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) | Terumo Europe N.V. | Jul 8, 2025 | SESE | | [K243309](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K243309.md) | 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) | Terumo Europe N.V. | May 29, 2025 | SESE | | [K240355](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K240355.md) | FROG (Filter Removal of Glass) | Carrtech Corp | Apr 18, 2025 | SESE | | [K243581](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K243581.md) | K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) | Terumo Europe N.V. | Apr 4, 2025 | SESE | | [K250658](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K250658.md) | SureFine Pen Needle | Shina Med Corporation | Apr 3, 2025 | SESE | | [K243806](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K243806.md) | Safety Winged Blood Collection Sets | Promisemed Hangzhou Meditech Co., Ltd. | Jan 10, 2025 | SESE | | [K242741](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K242741.md) | ACE Cannula | Ace Medical Industry Co., Ltd. | Jan 8, 2025 | SESE | | [K242632](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K242632.md) | Verifine® Pen Needles | Promisemed Hangzhou Meditech Co., Ltd. | Sep 26, 2024 | SESE | | [K240915](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K240915.md) | ZIEN IO Intraosseous Access System | Zien Medical Technologies, Inc. | Jul 2, 2024 | SESE | | [K232165](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K232165.md) | 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](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K233037.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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