Safety Pen Needle
FDA 510(k) K253622 · Ningbo Medsun Medical Co., Ltd.
510(k) numberK253622
Submission
- Device name
- Safety Pen Needle
- Applicant
- Ningbo Medsun Medical Co., Ltd.
Ningbo, CN - Received
- November 18, 2025
- Decision date
- March 18, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| K252886 | Pen NeedleFMI · Traditional | Hh Global Technology, Inc. | 01/06/2026SE |
More from Hh Global Technology, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253605 | Safety Heel LancetFMK · Traditional | 02/20/2026SE |
| K242627 | Safety LancetFMK · Traditional | 10/30/2024SE |
| K242316 | Safety LancetFMK · Special | 08/28/2024SE |
| K232330 | Lancing SystemQRK · Traditional | 01/04/2024SE |
| K221178 | Disposable Insulin Pen NeedleFMI · Traditional | 11/17/2022SE |
| K222090 | Safety LancetFMK · Traditional | 09/30/2022SE |
Questions and answers
When was Safety Pen Needle cleared by the FDA?
Safety Pen Needle (K253622) received a 510(k) decision of Substantially Equivalent on March 18, 2026, 120 days after the submission was received.
What is the product code of K253622?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.