# K123766: Novopen Echo, a Dial a Dose Insulin Delivery Pen

- Pathway: 510(k) (Traditional)
- Applicant: Novo Nordisk, Inc.
- Decided: Aug 15, 2013 after 251 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010359 (2001). 1 ancestor in all.
28 later devices descend from it; 3 cite it directly.
1 of 30 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010359: Innovo, Novo Nordisk A/S (2001)

## Most influential descendants
- K160629: InPen (2016), 21 descendants of its own
- K190487: InPen Dose Calculator (2020), 10 descendants of its own
- K201337: InPen System (2020), 7 descendants of its own
- K242775: InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) (2024), 6 descendants of its own
- K150874: NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) (2015), 5 descendants of its own

## Recalls of this device
- Jul 5, 2017 · Class II · Z-0206-2018: A small number of batches may crack or break if exposed to certain chemicals, like certain cleaning agents.

## Indications for use
The NovoPen Echo® is a re-usable pen injector designed for single patient use by diabetics for the self-injection of a desired dose of insulin. The pen injector uses PenFill 3.0 mL cartridges of Novo Nordisk insulin and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments.

Source page: https://510kreport.com/device/K123766
Methodology: https://510kreport.com/methodology