Clickfine Pen Needle, Penfine Classic Pen Needle
FDA 510(k) K171984 · Ypsomed AG
510(k) numberK171984
Submission
- Device name
- Clickfine Pen Needle, Penfine Classic Pen Needle
- Applicant
- Ypsomed AG
Burgdorf, CH - Received
- June 30, 2017
- Decision date
- October 11, 2017
- 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 |
| K163400 | Orbit InserterKZH · Traditional | 07/26/2017SE |
| K150921 | Orbit Infusion SetFPA · Traditional | 04/12/2016SE |
| K152514 | Clickfine AutoProtect Pen NeedleFMI · Special | 11/18/2015SE |
| K150662 | Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)FMI · Special | 06/09/2015SE |
| 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 cleared by the FDA?
Clickfine Pen Needle, Penfine Classic Pen Needle (K171984) received a 510(k) decision of Substantially Equivalent on October 11, 2017, 103 days after the submission was received.
What is the product code of K171984?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.