# K011519: Ameda Hygienikit

- Pathway: 510(k) (Traditional)
- Applicant: Hollister, Inc.
- Decided: Aug 15, 2001 after 90 days
- Product code: HGY (Pump, Breast, Non-Powered)
- Device class: 1
- Regulation: 21 CFR 884.5150
- Recalls of this device: 1 (0 Class I)
- 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 has not posted a summary or statement for it, so its predicates are not known.

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

## Recalls of this device
- Feb 12, 2015 · Class II · Z-1327-2015: Devices were not sterilized

Source page: https://510kreport.com/device/K011519
Methodology: https://510kreport.com/methodology