# K253498: Pump In Style® Pro+

- Pathway: 510(k) (Special)
- Applicant: Medela, LLC
- Decided: Jan 22, 2026 after 85 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: 5 generations back to K801862 (1980). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200508: Pump In Style, Medela, LLC (2020) Summary page 5.

## Indications for use
The Pump In Style® Pro+ breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The powered breast pump is intended for a single user. This breast pump is intended to be used in a home environment.

Source page: https://510kreport.com/device/K253498
Methodology: https://510kreport.com/methodology