Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle
FDA 510(k) K220204 · Anhui Tiankang Medical Technology Co., Ltd.
510(k) numberK220204
Submission
- Device name
- Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle
- Applicant
- Anhui Tiankang Medical Technology Co., Ltd.
Tianchang, CN - Received
- January 25, 2022
- Decision date
- July 14, 2022
- 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 |
|---|---|---|
| K222773 | Feeding TubePIF · Traditional | 08/17/2023SE |
| K222772 | Oral/Enteral Syringe with ENFit connectorPNR · Traditional | 08/17/2023SE |
| K230756 | TK Pre-Filled Normal Saline Flush SyringeNGT · Traditional | 08/12/2023SE |
| K222385 | Bifurcated NeedleSCL · Traditional | 12/06/2022SE |
| K212368 | Surgical Face MaskFXX · Traditional | 10/24/2021SE |
| K210464 | Auto Disable SyringeFMF · Traditional | 08/24/2021SE |
| K191639 | TK Insulin Syringe with/without Saftey Retractable DeviceMEG · Traditional | 09/11/2020SE |
| K191640 | TK Intravascular Administration SetFPA · Traditional | 08/26/2020SE |
| K191644 | TK Safety NeedleFMI · Traditional | 08/06/2020SE |
| K191642 | TK Sterile Piston Syringe without NeedleFMF · Traditional | 01/06/2020SE |
Questions and answers
When was Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle cleared by the FDA?
Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle (K220204) received a 510(k) decision of Substantially Equivalent on July 14, 2022, 170 days after the submission was received.
What is the product code of K220204?
The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.