FMI — Needle, Hypodermic, Single Lumen Class II
FDA product code FMI covers "Needle, Hypodermic, Single Lumen", a Class II medical device regulated under 21 CFR 880.5570. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K261266 | pentamaster mediq | MOWANA Auto Duo | September 17, 2026 |
| K261719 | promisemed hangzhou meditech co | Promisemed X-Safety Pen Needle | August 25, 2026 |
| K262427 | hh global technology | Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, | August 10, 2026 |
| K260933 | hangzhou qiantang longyue biotechnology co | Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, N | August 7, 2026 |
| K261829 | cmt health pte | Profoject Dual-Safety Pen Needles | July 29, 2026 |
| K260739 | cmt health pte | Profoject Pen Needles (Model A; Model B) | July 15, 2026 |
| K260855 | cmt health pte | Profoject Safety Pen Needles | June 10, 2026 |
| K254273 | promisemed hangzhou meditech co | Verisafe Safety Sterile Needles (SSN) | April 16, 2026 |
| K252908 | sandstone medical (suzhou) | Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen | March 25, 2026 |
| K253047 | nipro medical corporation | PRESSONE | March 24, 2026 |
| K253622 | ningbo medsun medical co | Safety Pen Needle | March 18, 2026 |
| 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 |