Cleared Special

K150874 - NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K150874 · Novo Nordisk, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Jul 2015
Decision
121d
Days
Class 2
Risk

K150874 is an FDA 510(k) clearance for the NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector). Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Novo Nordisk, Inc. (Plainsboro, US). The FDA issued a Cleared decision on July 31, 2015 after a review of 121 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Novo Nordisk, Inc. devices

Submission Details

510(k) Number K150874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2015
Decision Date July 31, 2015
Days to Decision 121 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 128d · This submission: 121d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 748
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