FDA 510(k)

NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)

K-Number: K182387 · 2018-12-17

Decision Date2018-12-17

Product CodeFMF

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) is a medical device manufactured by Novo Nordisk, Inc.. It received FDA 510(k) clearance on 2018-12-17 under approval number K182387. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)?

NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) is a medical device that received FDA 510(k) clearance on 2018-12-17. It is manufactured by Novo Nordisk, Inc.. The 510(k) number is K182387.

When was NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) approved by the FDA?

NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) received FDA 510(k) clearance on 2018-12-17, under approval number K182387.

What company makes NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)?

NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) is manufactured by Novo Nordisk, Inc..

What is the FDA product code for NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)?

The FDA product code for NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) is FMF.

Related Clinical Trials

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Related PubMed Literature

PMID: 41967377 Governing the rise of AI in healthcare: A comparative governance document and implementation implications across five jurisdictions. Social science & medicine (1982) (2026) PMID: 40965839 A multi-stakeholder perspective on medical devices for children and adolescents with type 1 diabetes: huge unmet needs for the smallest. Journal of pediatric endocrinology & metabolism : JPEM (2025) PMID: 40553217 Device reps in theatre: blurred boundaries or regulatory gaps? Monash bioethics review (2025) PMID: 39855465 [Review of practices concerning the delivery of an international implant card following the implantation of a medical device]. Annales pharmaceutiques francaises (2025)

Other Devices by Novo Nordisk, Inc.

K162602NovoPen Echo K173479NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) K202005NovoFine Plus 32G Tip x 4 mm K210258NovoFine K231255NovoFine® Plus

Related Devices (Code: FMF)

K162180Disposable Insulin SyringeBerpu Medical Technology Co., Ltd. K162081BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin SyringeBecton, Dickinson and Company K162602NovoPen EchoNovo Nordisk, Inc. K161568Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. K152879Sure-Fine Insulin SyringesShina Med Corporation K160629InPenCompanion Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.