Insulin Pen Needle
FDA 510(k) K153706 · SteriLance Medical (Suzhou), Inc.
510(k) numberK153706
Submission
- Device name
- Insulin Pen Needle
- Applicant
- SteriLance Medical (Suzhou), Inc.
Suzhou, CN - Received
- December 23, 2015
- Decision date
- August 29, 2016
- 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 |
|---|---|---|
| K262631 | Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)QRK · Special | 08/25/2026SE |
| K260122 | Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)QRL · Traditional | 07/06/2026SE |
| K261634 | Disposable Blood Lancet (Soft)QRK · Special | 06/12/2026SE |
| K244036 | Heel Incision Safety Lancet (SteriHeel 2)FMK · Traditional | 02/26/2025SE |
| K244031 | Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood…QRK · Traditional | 02/26/2025SE |
| K233796 | Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable…FMK · Traditional | 01/16/2024SE |
| K221521 | Disposable Safety LancetFMK · Traditional | 10/28/2022SE |
| K221507 | Disposable Blood LancetQRK · Traditional | 08/31/2022SE |
| K221970 | Lancing deviceQRL · Traditional | 08/30/2022SE |
| K210745 | Heel Incision Safety LancetFMK · Traditional | 08/26/2021SE |
Questions and answers
When was Insulin Pen Needle cleared by the FDA?
Insulin Pen Needle (K153706) received a 510(k) decision of Substantially Equivalent on August 29, 2016, 250 days after the submission was received.
What is the product code of K153706?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.