# K013226: Evenflo Comfort Ease Manual Breast Pump Kit

- Pathway: 510(k) (Traditional)
- Applicant: Evenflo Company, Inc.
- Decided: Dec 20, 2001 after 84 days
- Product code: HGY (Pump, Breast, Non-Powered)
- Device class: 1
- Regulation: 21 CFR 884.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
Like the Predicate device, the proposed Evenflo Comfort Ease Manual Breast Pump is a non-powered, hand-operated (piston-type) suction device used to express milk from the breast of lactating women.

Source page: https://510kreport.com/device/K013226
Methodology: https://510kreport.com/methodology