JMS Syringe
FDA 510(k) K132321 · JMS North America Corporation
510(k) numberK132321
Submission
- Device name
- JMS Syringe
- Applicant
- JMS North America Corporation
Hayward, CA, US - Received
- July 25, 2013
- Decision date
- February 20, 2014
- 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 |
|---|---|---|
| K251877 | JMS CAVEO A.V. Fistula Needle SetFIE · Traditional | 08/15/2025SE |
| K172499 | NeoshieldONB · Traditional | 06/01/2018SE |
| K151017 | JMS Harmony A.V. Fistula Needle SetFIE · Special | 05/13/2015SE |
| K142564 | JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)FIE · Special | 12/23/2014SE |
| K121488 | JMS Safe Wing Cath (SWC)FOZ · Traditional | 03/05/2013SE |
| K112178 | JMS Apheresis Needle Set Wingeater(R) V2FIE · Special | 10/27/2011SE |
| K111948 | Wingeater V2FIE · Special | 10/24/2011SE |
| K110157 | Sysloc Mini V3FIE · Special | 02/11/2011SE |
| K093637 | JMS Blunt A. V. Fistula Needle Set with Site Preparation Tool Model 820-5300, 820-6300…FIE · Traditional | 02/09/2010SE |
| K082882 | A.V. Fistula Blunt Needle SetFIE · Traditional | 01/21/2009SE |
Questions and answers
When was JMS Syringe cleared by the FDA?
JMS Syringe (K132321) received a 510(k) decision of Substantially Equivalent on February 20, 2014, 210 days after the submission was received.
What is the product code of K132321?
The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.