# K875300: Medela Breast-Pump Lactina

- Pathway: 510(k) (Traditional)
- Applicant: Medela, Inc.
- Decided: Apr 6, 1988 after 99 days
- Product code: HGX (Pump, Breast, Powered)
- Device class: 2
- Regulation: 21 CFR 884.5160
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
149 later devices descend from it; 2 cite it directly.
0 of 150 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K973501: Expresse and Premier Powered Breast Pumps (1997), 148 descendants of its own
- 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

## Recalls of this device
- Aug 6, 2010 · Not classified · Z-2486-2010: The product sterility may be compromised due to possible pinholes in the rigid tray of the package.
- Aug 6, 2010 · Not classified · Z-2484-2010: The product sterility may be compromised due to possible pinholes in the rigid tray of the package.
- Aug 6, 2010 · Not classified · Z-2485-2010: The product sterility may be compromised due to possible pinholes in the rigid tray of the package.

Source page: https://510kreport.com/device/K875300
Methodology: https://510kreport.com/methodology