Verisafe Safety Sterile Needles (SSN)
FDA 510(k) K254273 · Promisemed Hangzhou Meditech Co., Ltd.
510(k) numberK254273
Submission
- Device name
- Verisafe Safety Sterile Needles (SSN)
- Applicant
- Promisemed Hangzhou Meditech Co., Ltd.
Hangzhou City, CN - Received
- December 30, 2025
- Decision date
- April 16, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
| K252886 | Pen NeedleFMI · Traditional | Hh Global Technology, Inc. | 01/06/2026SE |
More from Hh Global Technology, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261719 | Promisemed X-Safety Pen NeedleFMI · Special | 08/25/2026SE |
| K261196 | Promisemed VeriEcto Automatic Biopsy NeedlesKNW · Special | 05/12/2026SE |
| K261045 | Verifine Safety LancetsFMK · Special | 05/01/2026SE |
| K250192 | Verisafe Safety Retractable Insulin SyringesFMF · Traditional | 12/10/2025SE |
| K250961 | Blood collection tube holdersJKA · Traditional | 06/04/2025SE |
| K251138 | Promisemed Safety Huber NeedlesPTI · Special | 05/13/2025SE |
| K243332 | Promisemed Safety Huber NeedlesPTI · Special | 03/14/2025SE |
| K243806 | Safety Winged Blood Collection SetsFMI · Special | 01/10/2025SE |
| K240675 | Endoscopic Injection NeedlesFBK · Traditional | 10/04/2024SE |
| K242632 | Verifine® Pen NeedlesFMI · Special | 09/26/2024SE |
Questions and answers
When was Verisafe Safety Sterile Needles (SSN) cleared by the FDA?
Verisafe Safety Sterile Needles (SSN) (K254273) received a 510(k) decision of Substantially Equivalent on April 16, 2026, 107 days after the submission was received.
What is the product code of K254273?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.