# K950750: Medelas Breast Pump

- Pathway: 510(k) (Traditional)
- Applicant: Medela, Inc.
- Decided: Oct 16, 1995 after 241 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.
31 later devices descend from it; 9 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K031614: Medela Pump in Style Advanced Breast Pump (2003), 21 descendants of its own
- 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
- K022594: Playtex Breast Pump (2002), 3 descendants of its own

## Recalls of this device
- Apr 4, 2011 · Not classified · Z-2386-2011: The power adaptor (transformer) used with the Pump In Style Advanced family of breast pumps have power cords that may easily become damaged if not properly handled.

Source page: https://510kreport.com/device/K950750
Methodology: https://510kreport.com/methodology