# K983776: Evenflo Comfort Control Breast Pump, Evenflo Comfort Control Dual Breast Pump

- Pathway: 510(k) (Traditional)
- Applicant: Evenflo Co., Inc.
- Decided: Apr 26, 1999 after 182 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 K875300 (1988). 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)
- K901344: Medela Battery Operated Breast Pump, Medela, Inc. (1990) Summary page 1.
- K950750: Medelas Breast Pump, Medela, Inc. (1995) Summary page 1.
- K973501: Expresse and Premier Powered Breast Pumps, Ameda Medizintechnik AG (1997) Summary page 1.
- (no number) Little Hearts Deluxe Battery Breast Pump: named in the summary without a submission number

## Most influential descendants
- K093648: Simplisse Electric Breastfeeding Companion (2010), 0 descendants of its own

## Indications for use
The Evenflo Comfort Control Breast Pump and Comfort Control Dual Breast Pump are personal use battery/electric powered suction devices used to express milk from the breast of lactating women. These devices are not intended for hospital use.

Source page: https://510kreport.com/device/K983776
Methodology: https://510kreport.com/methodology