BD Emerald Single Use, Hypodermic Syringe
FDA 510(k) K113241 · Becton Dickinson
510(k) numberK113241
Submission
- Device name
- BD Emerald Single Use, Hypodermic Syringe
- Applicant
- Becton Dickinson
Franklin Lakes, NJ, US - Received
- November 2, 2011
- Decision date
- November 28, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K243062 | BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229)…PHC · Traditional | 06/20/2025SE |
| K170386 | BD Ultra-Fine Insulin Syringe, BD Ultra-Fine II Insulin Syringe, BD Insulin Syringes…FMF · Special | 04/12/2017SE |
| K163637 | BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL)LON · Traditional | 03/21/2017SE |
| K161810 | BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic…MDB · Traditional | 02/09/2017SE |
| K161306 | BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic VialMDB · Traditional | 08/08/2016SE |
| K160164 | BD Veritor System for Rapid Detection of Flu A + B Labratory KitPSZ · Special | 02/25/2016SE |
| K160161 | BD Veritor System for Rapid Detection of Flu A + B CLIA waived kitPSZ · Special | 02/24/2016SE |
| K150059 | BD FlowSmart SetFPA · Traditional | 04/28/2015SE |
| K141474 | Becton Dickinson Intelliport SystemPHC · Traditional | 12/18/2014SE |
| K140448 | BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified DNA AssayLSL · Traditional | 05/20/2014SE |
Questions and answers
When was BD Emerald Single Use, Hypodermic Syringe cleared by the FDA?
BD Emerald Single Use, Hypodermic Syringe (K113241) received a 510(k) decision of Substantially Equivalent on November 28, 2011, 26 days after the submission was received.
What is the product code of K113241?
The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.