Disposable Syringes & Needles
FDA 510(k) K854563 · Medelec Intl. Corp.
510(k) numberK854563
Submission
- Device name
- Disposable Syringes & Needles
- Applicant
- Medelec Intl. Corp.
Miami Beach, FL, US - Received
- November 14, 1985
- Decision date
- December 9, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K961013 | Disposable Needle ElectrodeIKT · Traditional | 12/20/1996SE |
| K935017 | TD50 ElectromyographJXE · Traditional | 07/28/1994SE |
| K922548 | Medelec 2110 and 2114 EEGGWQ · Traditional | 11/03/1992SE |
| K920127 | Electroencephalograph Recording SystemGWQ · Traditional | 06/10/1992SE |
| K912775 | Sapphire 4ME Emg/Ep SystemGWF · Traditional | 11/08/1991SE |
| K865106 | Prophylactic (Condom) Mr. JohnnyHIS · Traditional | 05/20/1987SE |
| K863491 | Blood Specimen Collection DevicesJKA · Traditional | 10/24/1986SE |
| K854622 | Prophylactic (Condom)HIS · Traditional | 04/11/1986SE |
| K854562 | Connector, Blood Tubing, Infusion T. Intravenous IBRZ · Traditional | 01/09/1986SE |
| K854860 | Blades, Scalpel Carbon SteetGES · Traditional | 12/24/1985SE |
Questions and answers
When was Disposable Syringes & Needles cleared by the FDA?
Disposable Syringes & Needles (K854563) received a 510(k) decision of Substantially Equivalent on December 9, 1985, 25 days after the submission was received.
What is the product code of K854563?
The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.