Insulin Pen Needle
FDA 510(k) K230043 · Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
510(k) numberK230043
Submission
- Device name
- Insulin Pen Needle
- Applicant
- Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
Anqing, CN - Received
- January 6, 2023
- Decision date
- September 20, 2023
- 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 |
|---|---|---|
| K234024 | HWJECT Auto-disable syringeFMF · Traditional | 03/19/2024SE |
| K230061 | Insulin SyringeFMF · Traditional | 11/30/2023SE |
| K223323 | Blood Collection Needle (with/without Needle Holder)JKA · Traditional | 03/24/2023SE |
| K222124 | Sterile Hypodermic Syringe with/without Needle, Hypodermic NeedleFMI · Traditional | 11/04/2022SE |
| K222141 | Safety Blood Collection Needle (Without Needle Holder)JKA · Traditional | 10/21/2022SE |
| K220900 | Safety Blood Collection Needles with/without Needle HolderJKA · Traditional | 08/10/2022SE |
| K220083 | LDV((Low Dead Volume )SyringeQNQ · Traditional | 05/25/2022SE |
| K214075 | Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection /…FMI · Traditional | 04/12/2022SE |
| K211555 | Hypodermic Safety Needle; Hypodermic Safety Needle with SyringeMEG · Traditional | 10/18/2021SE |
| K202188 | Safety Blood Collection Sets for Single UseJKA · Traditional | 02/19/2021SE |
Questions and answers
When was Insulin Pen Needle cleared by the FDA?
Insulin Pen Needle (K230043) received a 510(k) decision of Substantially Equivalent on September 20, 2023, 257 days after the submission was received.
What is the product code of K230043?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.