FMI
- Product code
- FMI
- Device name
- Needle, Hypodermic, Single Lumen
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.5570
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 693
510(k) clearances, last 3 years (30)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261719 | 2026-08-25 | Promisemed Hangzhou Meditech Co., Ltd. | Promisemed X-Safety Pen Needle | |
| K262427 | 2026-08-10 | Hh Global Technology, Inc. | Pen Needle (Ordinary Type I, Safety Type IIA, Safety | |
| K260933 | 2026-08-07 | Hangzhou Qiantang Longyue Biotechnolog | Safety Sterile Hypodermic Needles (NR-S1816R, NR-S19 | |
| K261829 | 2026-07-29 | CMT Health PTE., Ltd. | Profoject Dual-Safety Pen Needles | |
| K260739 | 2026-07-15 | CMT Health PTE., Ltd. | Profoject Pen Needles (Model A; Model B) | |
| K260855 | 2026-06-10 | CMT Health PTE., Ltd. | Profoject Safety Pen Needles | |
| K254273 | 2026-04-16 | Promisemed Hangzhou Meditech Co., Ltd. | Verisafe Safety Sterile Needles (SSN) | — |
| K252908 | 2026-03-25 | Sandstone Medical (Suzhou), Inc. | Easydrip Classic Pen Needle; Easydrip Plus Pen Needl | |
| K253047 | 2026-03-24 | Nipro Medical Corporation | PRESSONE | FDA |
| K253622 | 2026-03-18 | Ningbo Medsun Medical Co., Ltd. | Safety Pen Needle | |
| K252886 | 2026-01-06 | Hh Global Technology, Inc. | Pen Needle | |
| K250700 | 2025-11-21 | Terumo Corporation | Pen Injector Needle 32.5 | |
| K252631 | 2025-10-16 | CMT Health PTE., Ltd. | Profoject Disposable Needle | |
| K250724 | 2025-07-30 | Spectrum Vascular | Intraosseous Infusion Needles | |
| K250284 | 2025-07-24 | Tsk Laboratory, Japan | TSK SELECT Needle | |
| K251447 | 2025-07-08 | Terumo Europe N.V. | K-Pack Embrace Active Safety Needle (KNAS-2516RB, KN | |
| K243309 | 2025-05-29 | Terumo Europe N.V. | 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) | FDA |
| K240355 | 2025-04-18 | Carrtech Corp | FROG (Filter Removal of Glass) | |
| K243581 | 2025-04-04 | Terumo Europe N.V. | K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC | |
| K250658 | 2025-04-03 | Shina Med Corporation | SureFine Pen Needle | |
| K243806 | 2025-01-10 | Promisemed Hangzhou Meditech Co., Ltd. | Safety Winged Blood Collection Sets | |
| K242741 | 2025-01-08 | Ace Medical Industry Co., Ltd. | ACE Cannula | |
| K242632 | 2024-09-26 | Promisemed Hangzhou Meditech Co., Ltd. | Verifine® Pen Needles | |
| K240915 | 2024-07-02 | Zien Medical Technologies, Inc. | ZIEN IO Intraosseous Access System | |
| K232165 | 2024-02-01 | Berpu Medical Technology Co., Ltd. | Sterile Safety Hypodermic Needles for Single Use; St | |
| K233037 | 2023-12-12 | Zhejiang Kindly Medical Device Co., Lt | Sterile Hypodermic Needles for Single Use | |
| K233343 | 2023-11-27 | Ocuject, LLC | SteriCap Safety Needle; VitreJect Safety Needle | |
| K230070 | 2023-10-05 | Promamedical, Inc. | MESORAM® Hypodermic Needle (710301); MESORAM® Hypode | |
| K230043 | 2023-09-20 | Anhui Hongyu Wuzhou Medical Manufactur | Insulin Pen Needle | |
| K230959 | 2023-09-14 | Ocuject, LLC | VitreJect® Needle; OcuSafe® Needle |
Official FDA classification page: FMI
Classification and pathway per current FDA publications. Data from openFDA (CC0).