# K161532: Philips Avent Comfort Single/Twin Electric Breast Pump

- Pathway: 510(k) (Traditional)
- Applicant: Philips Consumer Lifestyle - Innovation Site Eindhoven
- Decided: Aug 29, 2016 after 88 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: 6 generations back to K801862 (1980). 10 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150499: Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty, Medela AG (2015) Summary page 4.

## Most influential descendants
- K201381: Philips Avent Single/Double electric breast pump Advanced (2020), 2 descendants of its own
- K250129: AViTA Breast Pump (2026), 0 descendants of its own
- K203383: Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62 (2020), 0 descendants of its own

## Indications for use
The Philips Avent Comfort Single/Twin Electric Breast Pump is intended to express and collect milk from the breast of a lactating woman. The device is intended for a single user.

Source page: https://510kreport.com/device/K161532
Methodology: https://510kreport.com/methodology