Pen Needle
FDA 510(k) K230635 · Jiangsu Caina Medical Co.,Ltd
510(k) numberK230635
Submission
- Device name
- Pen Needle
- Applicant
- Jiangsu Caina Medical Co.,Ltd
Jiangyin, CN - Received
- March 7, 2023
- Decision date
- June 2, 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 |
|---|---|---|
| K232781 | Safety Sliding Blood Collection SetJKA · Traditional | 03/07/2024SE |
| K233190 | ENFit AdaptorPIO · Traditional | 01/18/2024SE |
| K220184 | Pump Alignment SyringeFMF · Traditional | 07/21/2022SE |
| K211593 | Enteral Pump SyringePNR · Traditional | 09/30/2021SE |
| K210217 | Needleless ConnectorFPA · Traditional | 05/17/2021SE |
| K200463 | Huber Needle Infusion Set, Safety Huber Needle Infusion SetPTI · Traditional | 04/07/2021SE |
| K201356 | Plastic LOR SyringeCAZ · Traditional | 02/12/2021SE |
| K200027 | Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without…JKA · Traditional | 09/09/2020SE |
| K193022 | Retractable Safety Insulin SyringeMEG · Traditional | 07/20/2020SE |
| K193526 | Syringe with safety needle, Safety needleFMF · Traditional | 07/17/2020SE |
Questions and answers
When was Pen Needle cleared by the FDA?
Pen Needle (K230635) received a 510(k) decision of Substantially Equivalent on June 2, 2023, 87 days after the submission was received.
What is the product code of K230635?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.