Syringe with safety needle, Safety needle
FDA 510(k) K193526 · Jiangsu Caina Medical Co.,Ltd
510(k) numberK193526
Submission
- Device name
- Syringe with safety needle, Safety needle
- Applicant
- Jiangsu Caina Medical Co.,Ltd
Jiangyin, CN - Received
- December 19, 2019
- Decision date
- July 17, 2020
- 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 |
|---|---|---|
| K232781 | Safety Sliding Blood Collection SetJKA · Traditional | 03/07/2024SE |
| K233190 | ENFit AdaptorPIO · Traditional | 01/18/2024SE |
| K230635 | Pen NeedleFMI · Traditional | 06/02/2023SE |
| K220184 | Pump Alignment SyringeFMF · Traditional | 07/21/2022SE |
| K211593 | Enteral Pump SyringePNR · Traditional | 09/30/2021SE |
| K210217 | Needleless ConnectorFPA · Traditional | 05/17/2021SE |
| K200463 | Huber Needle Infusion Set, Safety Huber Needle Infusion SetPTI · Traditional | 04/07/2021SE |
| K201356 | Plastic LOR SyringeCAZ · Traditional | 02/12/2021SE |
| K200027 | Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without…JKA · Traditional | 09/09/2020SE |
| K193022 | Retractable Safety Insulin SyringeMEG · Traditional | 07/20/2020SE |
Questions and answers
When was Syringe with safety needle, Safety needle cleared by the FDA?
Syringe with safety needle, Safety needle (K193526) received a 510(k) decision of Substantially Equivalent on July 17, 2020, 211 days after the submission was received.
What is the product code of K193526?
The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.