Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)
FDA 510(k) K150662 · Ypsomed AG
510(k) numberK150662
Submission
- Device name
- Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)
- Applicant
- Ypsomed AG
Burgdorf, CH - Received
- March 13, 2015
- Decision date
- June 9, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMI – Needle, Hypodermic, Single Lumen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5570
- Specialty
- General Hospital
Other 510(k)s with product code FMI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261719 | Promisemed X-Safety Pen NeedleFMI · Special | Promisemed Hangzhou Meditech Co., Ltd. | 08/25/2026SE |
| K262427 | Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety…FMI · Special | Hh Global Technology, Inc. | 08/10/2026SE |
| K260933 | Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R…FMI · Traditional | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 08/07/2026SE |
| K261829 | Profoject Dual-Safety Pen NeedlesFMI · Traditional | CMT Health PTE., Ltd. | 07/29/2026SE |
| K260739 | Profoject Pen Needles (Model A; Model B)FMI · Traditional | CMT Health PTE., Ltd. | 07/15/2026SE |
| K260855 | Profoject Safety Pen NeedlesFMI · Traditional | CMT Health PTE., Ltd. | 06/10/2026SE |
| K254273 | Verisafe Safety Sterile Needles (SSN)FMI · Special | Promisemed Hangzhou Meditech Co., Ltd. | 04/16/2026SE |
| K252908 | Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle…FMI · Special | Sandstone Medical (Suzhou), Inc. | 03/25/2026SE |
| K253047 | PressoneFMI · Traditional | Nipro Medical Corporation | 03/24/2026SE |
| K253622 | Safety Pen NeedleFMI · Traditional | Ningbo Medsun Medical Co., Ltd. | 03/18/2026SE |
More from Ningbo Medsun Medical Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K243901 | SmartPilot YpsoMate NS-A2.25QOG · Traditional | 08/28/2025SE |
| K171984 | Clickfine Pen Needle, Penfine Classic Pen NeedleFMI · Special | 10/11/2017SE |
| K163400 | Orbit InserterKZH · Traditional | 07/26/2017SE |
| K150921 | Orbit Infusion SetFPA · Traditional | 04/12/2016SE |
| K152514 | Clickfine AutoProtect Pen NeedleFMI · Special | 11/18/2015SE |
| K131125 | Clickfine Pen NeedleFMI · Traditional | 07/05/2013SE |
| K131123 | Clickfine Autoprotect Pen NeedleFMI · Traditional | 07/05/2013SE |
| K130468 | Orbit Infusion SetFPA · Special | 03/19/2013SE |
| K110312 | Clickfine Autoprotect Pen NeedleFMI · Traditional | 01/26/2012SE |
| K102108 | Clickfine Pen NeedleFMI · Special | 11/23/2010SE |
Questions and answers
When was Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated) cleared by the FDA?
Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated) (K150662) received a 510(k) decision of Substantially Equivalent on June 9, 2015, 88 days after the submission was received.
What is the product code of K150662?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.