NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)
FDA 510(k) K182387 · Novo Nordisk, Inc.
510(k) numberK182387
Submission
- Device name
- NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)
- Applicant
- Novo Nordisk, Inc.
Plainsboro, NJ, US - Received
- September 4, 2018
- Decision date
- December 17, 2018
- 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 |
|---|---|---|
| K231255 | NovoFine® PlusFMI · Special | 08/25/2023SE |
| K210258 | NovoFineFMI · Traditional | 06/23/2021SE |
| K202005 | NovoFine Plus 32G Tip x 4 mmFMI · Traditional | 12/19/2020SE |
| K173479 | NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)FMI · Traditional | 01/17/2018SE |
| K162602 | NovoPen EchoFMF · Special | 10/18/2016SE |
| K150874 | NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)FMF · Special | 07/31/2015SE |
| K133738 | Novofine Plus 32G 4 MMFMI · Traditional | 05/21/2014SE |
| K123766 | Novopen Echo, a Dial a Dose Insulin Delivery PenFMF · Traditional | 08/15/2013SE |
| K093109 | Novotwist Needle, Models 30G * 8MM (1/3) 32 G Tip * 5 MM(1/5')FMI · Traditional | 06/18/2010SE |
| K090111 | Flexpen NeedleFMI · Traditional | 02/01/2010SE |
Questions and answers
When was NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) cleared by the FDA?
NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) (K182387) received a 510(k) decision of Substantially Equivalent on December 17, 2018, 104 days after the submission was received.
What is the product code of K182387?
The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.