Safe-Site Needle Cover
FDA 510(k) K905305 · North American Medical Products, Inc.
510(k) numberK905305
Submission
- Device name
- Safe-Site Needle Cover
- Applicant
- North American Medical Products, Inc.
Loudonville, NY, US - Received
- November 28, 1990
- Decision date
- February 12, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K001965 | Safe-Point Vac, Safe-Point M-D Blood Collection SystemsFMI · Traditional | 02/02/2001SE |
| K895948 | Port-O-Scope(Tm)EOQ · Traditional | 03/27/1990SE |
| K896072 | D.L. Scope OphthalmoscopeHLJ · Traditional | 11/27/1989SE |
| K862661 | D.L. Scope(R) OtoscopeERA · Traditional | 08/08/1986SE |
| K841778 | D.L. Scope Blade & HandleCCW · Traditional | 05/23/1984SE |
Questions and answers
When was Safe-Site Needle Cover cleared by the FDA?
Safe-Site Needle Cover (K905305) received a 510(k) decision of Substantially Equivalent on February 12, 1991, 76 days after the submission was received.
What is the product code of K905305?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.