# K182387: NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)

- Pathway: 510(k) (Traditional)
- Applicant: Novo Nordisk, Inc.
- Decided: Dec 17, 2018 after 104 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K010359 (2001). 4 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162602: NovoPen Echo, Novo Nordisk, Inc. (2016) Summary page 4.

## Most influential descendants
- K240961: Disposable Pen Injector Assembly (2024), 1 descendant of its own
- K253747: Disposable Pen Injector (KXYC-03C02, KXYC-03A03) (2026), 0 descendants of its own
- K240774: Pen Injector (2024), 0 descendants of its own

## Indications for use
The NovoPen Echo® is a re-useable 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 mL cartridge of NovoLog®, 100 units/mL (U-100) [insulin aspart injection], Fiasp® 100 units/mL (U-100) [insulin aspart injection], 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 0.5 unit increments.

Source page: https://510kreport.com/device/K182387
Methodology: https://510kreport.com/methodology