# K973501: Expresse and Premier Powered Breast Pumps

- Pathway: 510(k) (Traditional)
- Applicant: Ameda Medizintechnik AG
- Decided: Dec 11, 1997 after 86 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: 1 generation back to K875300 (1988). 2 ancestors in all.
148 later devices descend from it; 13 cite it directly.
0 of 151 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K875300: Medela Breast-Pump Lactina, Medela, Inc. (1988) Summary page 1.
- K950531: Egnell Elite, Hollister, Inc. (1995) Summary page 1.
- (no number) Medela Pump In Style Breast Pump: named in the summary without a submission number

## Most influential descendants
- K092783: DEBP (2009), 100 descendants of its own
- K122474: Lansinoh Powered Electric Breast Pump (2012), 63 descendants of its own
- K150499: Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty (2015), 55 descendants of its own
- K162415: Spectra 9Plus (2017), 32 descendants of its own
- K163136: Youha electric breast pump (2017), 30 descendants of its own

## Recalls of this device
- Jul 10, 2017 · Class III · Z-0616-2018: Two specific lots was incorrectly manufactured containing a UK power adapter.

## Indications for use
The Lactaline Personal Powered Breast Pumps (Premier/Expresse) are intended to express and collect the mother’s milk of a nursing woman for the purpose of feeding the collected milk to a baby.

Source page: https://510kreport.com/device/K973501
Methodology: https://510kreport.com/methodology