EXELINT SecureTouch Safety Hypodermic Needle
FDA 510(k) K152183 · Exelint International, Co.
510(k) numberK152183
Submission
- Device name
- EXELINT SecureTouch Safety Hypodermic Needle
- Applicant
- Exelint International, Co.
Redondo Beach, CA, US - Received
- August 5, 2015
- Decision date
- November 2, 2015
- 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 |
|---|---|---|
| K251089 | EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe…FMF · Traditional | 12/12/2025SE |
| K101309 | Exelint Aluminum Hub Blunt NeedlesLHI · Traditional | 10/20/2010SE |
| K020189 | Exel Butterfly Scalp Vein SetFPA · Traditional | 03/27/2003SE |
| K010197 | Exel Secure Touch Safety (P.S.V.) Scalp Vein SetFPA · Traditional | 05/14/2001SE |
| K003627 | Exel Secure Touch Safety A.V. Fistula Needle SetFMI · Traditional | 02/08/2001SE |
| K001496 | A.V. Fistula NeedleFIE · Traditional | 08/01/2000SE |
Questions and answers
When was EXELINT SecureTouch Safety Hypodermic Needle cleared by the FDA?
EXELINT SecureTouch Safety Hypodermic Needle (K152183) received a 510(k) decision of Substantially Equivalent on November 2, 2015, 89 days after the submission was received.
What is the product code of K152183?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.