Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set
FDA 510(k) K182146 · Sol-Millennium Medical, Inc.
510(k) numberK182146
Submission
- Device name
- Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set
- Applicant
- Sol-Millennium Medical, Inc.
Lawrenceville, GA, US - Received
- August 8, 2018
- Decision date
- December 3, 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 |
|---|---|---|
| K252184 | SOL-M Luer Lock Syringe with Exchangeable Needle TrayFMF · Traditional | 08/25/2026SE |
| K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeFMF · Traditional | 06/18/2026SE |
| K250907 | Sol-Guard TM XtraThin Safety Pull-Button Blood Collection SetJKA · Special | 04/30/2025SE |
| K242291 | SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead…QNQ · Traditional | 11/20/2024SE |
| K242099 | Sol-M Slip Tip Syringe without Needle, Sol-M Eccentric Tip Syringe without NeedleFMF · Traditional | 10/22/2024SE |
| K241821 | Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer…FMF · Traditional | 09/20/2024SE |
| K220713 | Sol-Guard Auto-disable SyringeFMF · Traditional | 05/04/2023SE |
| K222744 | Sol-M Luer Lock SyringeFMF · Special | 10/11/2022SE |
| K213718 | SOL-GUARD Safety Pull Button Collection SetJKA · Traditional | 08/30/2022SE |
| K163073 | Sol-Care Safety Blood Collection Needle with and without Pre-Attached HolderJKA · Traditional | 05/19/2017SE |
Questions and answers
When was Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set cleared by the FDA?
Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set (K182146) received a 510(k) decision of Substantially Equivalent on December 3, 2018, 117 days after the submission was received.
What is the product code of K182146?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.