FMI — Needle, Hypodermic, Single Lumen Class II
FDA Device Classification
Classification Details
- Product Code
- FMI
- Device Class
- Class II
- Regulation Number
- 880.5570
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K252886 | hh global technology | Pen Needle | January 6, 2026 |
| K250700 | terumo corporation | Pen Injector Needle 32.5 | November 21, 2025 |
| K252631 | cmt health pte | Profoject Disposable Needle | October 16, 2025 |
| K250724 | spectrum vascular | Intraosseous Infusion Needles | July 30, 2025 |
| K250284 | tsk laboratory, japan | TSK SELECT Needle | July 24, 2025 |
| K251447 | terumo europe n.v | K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) | July 8, 2025 |
| K243309 | terumo europe n.v | 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) | May 29, 2025 |
| K240355 | carrtech | FROG (Filter Removal of Glass) | April 18, 2025 |
| K243581 | terumo europe n.v | K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) | April 4, 2025 |
| K250658 | shina med corporation | SureFine Pen Needle | April 3, 2025 |
| K243806 | promisemed hangzhou meditech co | Safety Winged Blood Collection Sets | January 10, 2025 |
| K242741 | ace medical industry co | ACE Cannula | January 8, 2025 |
| K242632 | promisemed hangzhou meditech co | Verifine® Pen Needles | September 26, 2024 |
| K240915 | zien medical technologies | ZIEN IO Intraosseous Access System | July 2, 2024 |
| K232165 | berpu medical technology co | Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for | February 1, 2024 |
| K233037 | zhejiang kindly medical device co | Sterile Hypodermic Needles for Single Use | December 12, 2023 |
| K233343 | ocuject | SteriCap Safety Needle; VitreJect Safety Needle | November 27, 2023 |
| K230070 | promamedical | MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302); MESORA | October 5, 2023 |
| K230043 | anhui hongyu wuzhou medical manufacturer co | Insulin Pen Needle | September 20, 2023 |
| K230959 | ocuject | VitreJect® Needle; OcuSafe® Needle | September 14, 2023 |