Sol-M Insulin Syringe, Sol-M TB Syringe
FDA 510(k) K153537 · Sol-Millennium Medical, Inc.
510(k) numberK153537
Submission
- Device name
- Sol-M Insulin Syringe, Sol-M TB Syringe
- Applicant
- Sol-Millennium Medical, Inc.
Lawrenceville, GA, US - Received
- December 10, 2015
- Decision date
- June 17, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMF – Syringe, Piston
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5860
- Specialty
- General Hospital
Other 510(k)s with product code FMF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262581 | GraftGun Universal Graft Delivery System (GDS®)FMF · Special | SurGenTec, LLC | 08/26/2026SE |
| K252184 | SOL-M Luer Lock Syringe with Exchangeable Needle TrayFMF · Traditional | Sol-Millennium Medical, Inc. | 08/25/2026SE |
| K253747 | Disposable Pen Injector (KXYC-03C02, KXYC-03A03)FMF · Traditional | Jiangsu Enjosim Medical Technology Co., Ltd. | 08/14/2026SE |
| K260208 | Ultra-Fine SAFETY Insulin SyringeFMF · Traditional | embecta Medical II, LLC | 07/13/2026SE |
| K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeFMF · Traditional | Sol-Millennium Medical, Inc. | 06/18/2026SE |
| K260514 | Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead…FMF · Traditional | CMT Health PTE., Ltd. | 06/12/2026SE |
| K253112 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…FMF · Special | Hlb Lifescience Co., Ltd. | 05/21/2026SE |
| K252279 | Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)FMF · Traditional | Chirana T.Injecta,A.S. | 04/17/2026SE |
| K253068 | Profoject Insulin Syringes; Profoject Safelock Disposable Insulin SyringeFMF · Traditional | CMT Health PTE., Ltd. | 02/23/2026SE |
| K253769 | Instylla Delivery KitFMF · Special | Instylla, Inc. | 12/22/2025SE |
More from Instylla, Inc.
| 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 |
| K182146 | Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care…FMI · Traditional | 12/03/2018SE |
Questions and answers
When was Sol-M Insulin Syringe, Sol-M TB Syringe cleared by the FDA?
Sol-M Insulin Syringe, Sol-M TB Syringe (K153537) received a 510(k) decision of Substantially Equivalent on June 17, 2016, 190 days after the submission was received.
What is the product code of K153537?
The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.