Syringe with permanently attached needle
FDA 510(k) K213158 · Berpu Medical Technology Co., Ltd.
510(k) numberK213158
Submission
- Device name
- Syringe with permanently attached needle
- Applicant
- Berpu Medical Technology Co., Ltd.
Wenzhou, CN - Received
- September 28, 2021
- Decision date
- July 21, 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 |
|---|---|---|
| K232165 | Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single…FMI · Traditional | 02/01/2024SE |
| K221045 | Insulin Syringes without needleFMF · Traditional | 11/03/2022SE |
| K220061 | Safety Insulin SyringesMEG · Traditional | 08/23/2022SE |
| K213811 | Sterile Hypodermic Syringes for Single UseFMF · Traditional | 05/12/2022SE |
| K212514 | Safety Pen Needle for Single Use, Insulin Pen NeedlesFMI · Traditional | 04/29/2022SE |
| K181447 | Safety insulin needle for single useFMI · Traditional | 03/12/2019SE |
| K180417 | Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single…MEG · Traditional | 08/09/2018SE |
| K162180 | Disposable Insulin SyringeFMF · Traditional | 12/29/2016SE |
Questions and answers
When was Syringe with permanently attached needle cleared by the FDA?
Syringe with permanently attached needle (K213158) received a 510(k) decision of Substantially Equivalent on July 21, 2022, 296 days after the submission was received.
What is the product code of K213158?
The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.