HWJECT Auto-disable syringe
FDA 510(k) K234024 · Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
510(k) numberK234024
Submission
- Device name
- HWJECT Auto-disable syringe
- Applicant
- Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
Anqing, CN - Received
- December 20, 2023
- Decision date
- March 19, 2024
- 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 |
|---|---|---|
| K230061 | Insulin SyringeFMF · Traditional | 11/30/2023SE |
| K230043 | Insulin Pen NeedleFMI · Traditional | 09/20/2023SE |
| K223323 | Blood Collection Needle (with/without Needle Holder)JKA · Traditional | 03/24/2023SE |
| K222124 | Sterile Hypodermic Syringe with/without Needle, Hypodermic NeedleFMI · Traditional | 11/04/2022SE |
| K222141 | Safety Blood Collection Needle (Without Needle Holder)JKA · Traditional | 10/21/2022SE |
| K220900 | Safety Blood Collection Needles with/without Needle HolderJKA · Traditional | 08/10/2022SE |
| K220083 | LDV((Low Dead Volume )SyringeQNQ · Traditional | 05/25/2022SE |
| K214075 | Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection /…FMI · Traditional | 04/12/2022SE |
| K211555 | Hypodermic Safety Needle; Hypodermic Safety Needle with SyringeMEG · Traditional | 10/18/2021SE |
| K202188 | Safety Blood Collection Sets for Single UseJKA · Traditional | 02/19/2021SE |
Questions and answers
When was HWJECT Auto-disable syringe cleared by the FDA?
HWJECT Auto-disable syringe (K234024) received a 510(k) decision of Substantially Equivalent on March 19, 2024, 90 days after the submission was received.
What is the product code of K234024?
The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.