Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use
FDA 510(k) K212857 · Jiangsu Zhiyu Medical Instrument Co, Ltd.
510(k) numberK212857
Submission
- Device name
- Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use
- Applicant
- Jiangsu Zhiyu Medical Instrument Co, Ltd.
Taixing, CN - Received
- September 8, 2021
- Decision date
- May 9, 2023
- 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 |
Questions and answers
When was Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use cleared by the FDA?
Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use (K212857) received a 510(k) decision of Substantially Equivalent on May 9, 2023, 608 days after the submission was received.
What is the product code of K212857?
The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.