Product code FMI
- Device name
- Needle, Hypodermic, Single Lumen
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5570
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254273 | Verisafe Safety Sterile Needles (SSN) | Promisemed Hangzhou Meditech Co., Ltd. | 2026-04-16 |
| K252908 | Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle | Sandstone Medical (Suzhou), Inc. | 2026-03-25 |
| K253047 | PRESSONE™ | Nipro Medical Corporation | 2026-03-24 |
| K253622 | Safety Pen Needle | Ningbo Medsun Medical Co., Ltd. | 2026-03-18 |
| K252886 | Pen Needle | Hh Global Technology, Inc. | 2026-01-06 |
| K250700 | Pen Injector Needle 32.5 | Terumo Corporation | 2025-11-21 |
| K252631 | Profoject™ Disposable Needle | CMT Health PTE., Ltd. | 2025-10-16 |
| K250724 | Intraosseous Infusion Needles | Spectrum Vascular | 2025-07-30 |
| K250284 | TSK SELECT™ Needle | Tsk Laboratory, Japan | 2025-07-24 |
| K251447 | K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) | Terumo Europe N.V. | 2025-07-08 |
| K243309 | 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) | Terumo Europe N.V. | 2025-05-29 |
| K240355 | FROG (Filter Removal of Glass) | Carrtech Corp | 2025-04-18 |
| K243581 | K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) | Terumo Europe N.V. | 2025-04-04 |
| K250658 | SureFine Pen Needle | Shina Med Corporation | 2025-04-03 |
| K243806 | Safety Winged Blood Collection Sets | Promisemed Hangzhou Meditech Co., Ltd. | 2025-01-10 |
| K242741 | ACE Cannula | Ace Medical Industry Co., Ltd. | 2025-01-08 |
| K242632 | Verifine® Pen Needles | Promisemed Hangzhou Meditech Co., Ltd. | 2024-09-26 |
| K240915 | ZIEN IO Intraosseous Access System | Zien Medical Technologies, Inc. | 2024-07-02 |
| 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. | 2024-02-01 |
| K233037 | Sterile Hypodermic Needles for Single Use | Zhejiang Kindly Medical Device Co., Ltd. | 2023-12-12 |
| K233343 | SteriCap Safety Needle; VitreJect Safety Needle | Ocuject, LLC | 2023-11-27 |
| K230070 | MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302); MESORAM® Hypodermic Needle (712305); MESORAM® Hypodermic Needle (712315); MESORAM® Hypodermic Needle (710303); MESORAM® Hypodermic Needle (710307); MESORAM® Hypode... | Promamedical, Inc. | 2023-10-05 |
| K230043 | Insulin Pen Needle | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2023-09-20 |
| K230959 | VitreJect® Needle; OcuSafe® Needle | Ocuject, LLC | 2023-09-14 |
| K231729 | Sterile syringes for single use with/without needle | Wepon Medical Technology Co., Ltd. | 2023-09-08 |
| K231723 | Sterile Safety Hypodermic Needles for Single Use | Wepon Medical Technology Co., Ltd. | 2023-09-08 |
| K231720 | Sterile Hypodermic Needles for Single Use | Wepon Medical Technology Co., Ltd. | 2023-09-08 |
| K231255 | NovoFine® Plus | Novo Nordisk, Inc. | 2023-08-25 |
| K231261 | Altaviz Needle Kit II | Altaviz, LLC | 2023-07-27 |
| K231924 | EZ-IO Intraosseous Vascular Access System | Teleflex Medical | 2023-07-25 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840464800026 | Intraosseous Infusion Needles | Ecs Opco 1 LLC | 2026-05-27 |
| 00840464800033 | Intraosseous Infusion Needles | Ecs Opco 1 LLC | 2026-05-27 |
| 00840464800040 | Intraosseous Infusion Needles | Ecs Opco 1 LLC | 2026-05-27 |
| 00840464800057 | Intraosseous Infusion Needles | Ecs Opco 1 LLC | 2026-05-27 |
| 00840464800064 | Intraosseous Infusion Needles | Ecs Opco 1 LLC | 2026-05-27 |
| 10840330704868 | ProCure | Twin Med, LLC | 2026-05-27 |
| 10840330704875 | ProCure | Twin Med, LLC | 2026-05-27 |
| 00840464800019 | Intraosseous Infusion Needles | Ecs Opco 1 LLC | 2026-05-27 |
| 07613117034818 | Penfine Classic Pen Needles | Ypsomed AG | 2023-06-19 |
| 07613117034849 | Penfine Classic Pen Needles | Ypsomed AG | 2023-06-19 |
| 07613117034764 | Penfine Classic Pen Needles | Ypsomed AG | 2023-06-19 |
| 07613117032302 | Clickfine Pen Needles | Ypsomed AG | 2022-08-25 |
| 07613117026264 | Clickfine AutoProtect | Ypsomed AG | 2022-04-27 |
| 07613117031282 | Clickfine pen needles | Ypsomed AG | 2021-11-01 |
| G001N25150 | Shifeng | Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. | 2020-12-01 |
| G001N25100 | Shifeng | Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. | 2020-12-01 |
| G001N23100 | Shifeng | Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. | 2020-11-19 |
| 08498840006917 | VYGON | Vygon Corporation | 2016-08-18 |
| 08498840006894 | VYGON | Vygon Corporation | 2016-08-18 |
| 08498840006887 | VYGON | Vygon Corporation | 2016-08-18 |
| 08498840006948 | VYGON | Vygon Corporation | 2016-08-16 |
| 08498840006931 | VYGON | Vygon Corporation | 2016-08-16 |
| 08498840006924 | VYGON | Vygon Corporation | 2016-08-16 |
| 08498840006900 | VYGON | Vygon Corporation | 2016-08-16 |
| 08498840006863 | VYGON | Vygon Corporation | 2016-08-16 |
| 08498840006856 | VYGON | Vygon Corporation | 2016-08-16 |
| 08498840006849 | VYGON | Vygon Corporation | 2016-08-16 |
| 08498840006832 | VYGON | Vygon Corporation | 2016-08-16 |
| 08498840006825 | VYGON | Vygon Corporation | 2016-08-16 |
| 08498840006818 | VYGON | Vygon Corporation | 2016-08-16 |