# K100435: Ameda Platinum Breast Pump

- Pathway: 510(k) (Traditional)
- Applicant: Evenflo Company, Inc.
- Decided: May 28, 2010 after 101 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: 2 generations back to K801862 (1980). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020518: Medela Symphony Breast Pump, Model 024, Medela, Inc. (2002) Summary page 1.
- K950531: Egnell Elite, Hollister, Inc. (1995) Summary page 2.
- K052909: Evenflo Elan Breast Pump, Evenflo Company, Inc. (2005) Summary page 1.
- K011519: Ameda Hygienikit, Hollister, Inc. (2001)

## Most influential descendants
- K132882: Electric Breast Pump (2014), 0 descendants of its own

## Indications for use
The Ameda Platinum Breast Pump is intended to express and collect milk from the mother's breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs.

Source page: https://510kreport.com/device/K100435
Methodology: https://510kreport.com/methodology