# K181863: Elvie Pump

- Pathway: 510(k) (Traditional)
- Applicant: Chiaro Technology Limited
- Decided: Oct 10, 2018 after 90 days
- Product code: HGX (Pump, Breast, Powered)
- Device class: 2
- Regulation: 21 CFR 884.5160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K801862 (1980). 10 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150499: Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty, Medela AG (2015) Summary page 4.

## Most influential descendants
- K210936: Elvie Stride (2021), 5 descendants of its own
- K231785: Perifit Pump (2024), 2 descendants of its own
- K202037: imani i2 (2021), 2 descendants of its own
- K220926: Spectra Wearable (2022), 1 descendant of its own
- K250208: SPECTRA Wearable 2 (2026), 0 descendants of its own

## Indications for use
The Elvie Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Elvie Pump is intended for a single user.

Source page: https://510kreport.com/device/K181863
Methodology: https://510kreport.com/methodology