Immucise Intradermal Injection System
FDA 510(k) K181369 · Terumo Corporation
510(k) numberK181369
Submission
- Device name
- Immucise Intradermal Injection System
- Applicant
- Terumo Corporation
Shibuya-Ku, JP - Received
- May 23, 2018
- Decision date
- November 13, 2018
- 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 |
|---|---|---|
| K252295 | RyureiLOX · Traditional | 03/27/2026SE |
| K250700 | Pen Injector Needle 32.5FMI · Traditional | 11/21/2025SE |
| K250751 | DualView CatheterDQO · Traditional | 07/17/2025SE |
| K240818 | R2P Radifocus Glidewire AdvantageDQX · Traditional | 11/26/2024SE |
| K240859 | Glidewire GT-RDQX · Traditional | 08/21/2024SE |
| K190427 | ImmuciseFMF · Traditional | 07/18/2019SE |
| K173799 | NaviCross 0.018DQY · Traditional | 03/29/2018SE |
| K170417 | Glidewire GTDQX · Traditional | 09/15/2017SE |
| K130493 | Capiox RX05 Hollow Fiber Oxygenator/ReservoirDTZ · Special | 03/13/2013SE |
| K130280 | Capiox FX Hollow Fiber Oxygenator W/ ReservoirDTZ · Special | 03/13/2013SE |
Questions and answers
When was Immucise Intradermal Injection System cleared by the FDA?
Immucise Intradermal Injection System (K181369) received a 510(k) decision of Substantially Equivalent on November 13, 2018, 174 days after the submission was received.
What is the product code of K181369?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.