Safety insulin needle for single use
FDA 510(k) K181447 · Berpu Medical Technology Co., Ltd.
510(k) numberK181447
Submission
- Device name
- Safety insulin needle for single use
- Applicant
- Berpu Medical Technology Co., Ltd.
Wenzhou, CN - Received
- June 1, 2018
- Decision date
- March 12, 2019
- 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 |
|---|---|---|
| K232165 | Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single…FMI · Traditional | 02/01/2024SE |
| K221045 | Insulin Syringes without needleFMF · Traditional | 11/03/2022SE |
| K220061 | Safety Insulin SyringesMEG · Traditional | 08/23/2022SE |
| K213158 | Syringe with permanently attached needleFMF · Traditional | 07/21/2022SE |
| K213811 | Sterile Hypodermic Syringes for Single UseFMF · Traditional | 05/12/2022SE |
| K212514 | Safety Pen Needle for Single Use, Insulin Pen NeedlesFMI · Traditional | 04/29/2022SE |
| K180417 | Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single…MEG · Traditional | 08/09/2018SE |
| K162180 | Disposable Insulin SyringeFMF · Traditional | 12/29/2016SE |
Questions and answers
When was Safety insulin needle for single use cleared by the FDA?
Safety insulin needle for single use (K181447) received a 510(k) decision of Substantially Equivalent on March 12, 2019, 284 days after the submission was received.
What is the product code of K181447?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.