# K031614: Medela Pump in Style Advanced Breast Pump

- Pathway: 510(k) (Traditional)
- Applicant: Medela, Inc.
- Decided: Jun 6, 2003 after 14 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
Longest line of descent: 2 generations back to K801862 (1980). 4 ancestors in all.
21 later devices descend from it; 7 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020518: Medela Symphony Breast Pump, Model 024, Medela, Inc. (2002)
- K950750: Medelas Breast Pump, Medela, Inc. (1995) Summary page 1.

## Most influential descendants
- K181937: Pump In Style Advanced, Advanced Personal Double Breastpump (2018), 10 descendants of its own
- K200508: Pump In Style (2020), 8 descendants of its own
- K213311: Lucy Breast Pump (2022), 4 descendants of its own
- K111411: Freemie (R) (2012), 2 descendants of its own
- K102516: Lucina Model Melodi (2011), 2 descendants of its own

## Recalls of this device
- Jan 10, 2011 · Not classified · Z-1224-2011: The performance of the pumps may be compromised due to the potentiometer used on the circuit board. Affected pumps may not turn on, may turn off on its own, may reduce or lose suction during the pumpi

## Indications for use
The Pump in Style@Advanced Breastpump is a powered breastpump to be used by lactating women to express and collect milk from their breasts.

Source page: https://510kreport.com/device/K031614
Methodology: https://510kreport.com/methodology