SurGuard3 Safety Hypodermic Needle
FDA 510(k) K212095 · Terumo Europe N.V.
510(k) numberK212095
Submission
- Device name
- SurGuard3 Safety Hypodermic Needle
- Applicant
- Terumo Europe N.V.
Leuven, BE - Received
- July 6, 2021
- Decision date
- August 22, 2022
- 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 |
| K253622 | Safety Pen NeedleFMI · Traditional | Ningbo Medsun Medical Co., Ltd. | 03/18/2026SE |
More from Ningbo Medsun Medical Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K251447 | K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)FMI · Traditional | 07/08/2025SE |
| K243309 | 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)FMI · Special | 05/29/2025SE |
| K243581 | K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)FMI · Traditional | 04/04/2025SE |
| K230951 | Terumo Injection Filter Needle (NF-3013RBKE05M)QYM · Traditional | 10/18/2023SE |
| K192057 | K-Pack II Needle - 27G x 1/2 Extra Thin Wall, K-Pack II Needle - 27G x 1/2 Ultra Thin…FMI · Special | 10/11/2019SE |
| K161606 | Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSHFMF · Traditional | 02/10/2017SE |
| K151398 | K-Pack II Needle - 29G x 5/16 Thin WallFMI · Special | 06/25/2015SE |
| K150263 | K-Pack II Needle-21G x 2FMI · Special | 04/01/2015SE |
| K133894 | Surflo Winged Infusion Set with Filter & Needle Protection (Surshield)FPA · Traditional | 03/18/2014SE |
| K133867 | Surflo Winged Infusion Set with Needle Protection (Surshield)FPA · Special | 02/05/2014SE |
Questions and answers
When was SurGuard3 Safety Hypodermic Needle cleared by the FDA?
SurGuard3 Safety Hypodermic Needle (K212095) received a 510(k) decision of Substantially Equivalent on August 22, 2022, 412 days after the submission was received.
What is the product code of K212095?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.