Sterile Hypodermic Syringes for Single Use with Needles
FDA 510(k) K221068 · Sichuan Prius Biotechnology Co., Ltd.
510(k) numberK221068
Submission
- Device name
- Sterile Hypodermic Syringes for Single Use with Needles
- Applicant
- Sichuan Prius Biotechnology Co., Ltd.
Yibin, CN - Received
- April 12, 2022
- Decision date
- October 4, 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 |
|---|---|---|
| K221078 | Intravenous Needles for Single Use,Safety Intravenous Needles for Single UseFPA · Traditional | 11/21/2022SE |
| K221075 | Infusion Sets for Single UseFPA · Traditional | 11/21/2022SE |
| K221069 | Infusion Sets for Single Use with NeedlesFPA · Traditional | 11/21/2022SE |
| K221080 | Sterile Safety Hypodermic Needles for Single UseFMI · Traditional | 10/04/2022SE |
| K221079 | Sterile Hypodermic Syringes for Single UseFMF · Traditional | 10/04/2022SE |
| K221073 | Sterile Hypodermic Syringes for Single Use with Safety NeedlesMEG · Traditional | 10/04/2022SE |
| K221066 | Sterile Hypodermic Needles for Single UseFMI · Traditional | 10/04/2022SE |
| K210908 | Surgical MaskFXX · Traditional | 09/26/2021SE |
Questions and answers
When was Sterile Hypodermic Syringes for Single Use with Needles cleared by the FDA?
Sterile Hypodermic Syringes for Single Use with Needles (K221068) received a 510(k) decision of Substantially Equivalent on October 4, 2022, 175 days after the submission was received.
What is the product code of K221068?
The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.