# K092770: Simplygo Hands Free Breast Pump

- Pathway: 510(k) (Special)
- Applicant: Evenflo Company, Inc.
- Decided: Oct 9, 2009 after 30 days
- Product code: HGX (Pump, Breast, Powered)
- Device class: 2
- Regulation: 21 CFR 884.5160
- 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.
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.

## Recalls of this device
- Feb 22, 2016 · Class II · Z-1835-2016: Pentax Medical learned of reports of carbapenem-resistant Enterobacteriaceae (CRE) infection at a medical facility.

## Indications for use
The Simply Go TM Breast Pump is an electrically operated suction device used to express and collect milk from the breast(s) of lactating woman.

Source page: https://510kreport.com/device/K092770
Methodology: https://510kreport.com/methodology