# K052909: Evenflo Elan Breast Pump

- Pathway: 510(k) (Traditional)
- Applicant: Evenflo Company, Inc.
- Decided: Nov 1, 2005 after 15 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K100435: Ameda Platinum Breast Pump (2010), 1 descendant of its own
- K132882: Electric Breast Pump (2014), 0 descendants of its own

## Indications for use
The Evenflo Elan Breast Pump and the Evenflo Elan Dual Breast Pump are personal use battery and/or electric powered suction devices used to express milk from the breast(s) of lactating women.

Source page: https://510kreport.com/device/K052909
Methodology: https://510kreport.com/methodology