# K093145: Spectra Series Breast Pump

- Pathway: 510(k) (Traditional)
- Applicant: Uzinmedicare Co.
- Decided: Aug 13, 2010 after 312 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: 4 generations back to K875300 (1988). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061013: Playtex Embrace Petite Breast Pump, Playtex Products, Inc. (2006) Summary page 2.
- K950750: Medelas Breast Pump, Medela, Inc. (1995) Summary page 2.
- K973501: Expresse and Premier Powered Breast Pumps, Ameda Medizintechnik AG (1997) Summary page 2.

## Indications for use
The Spectra electric breast pump is Single user product and intended to express breast milk from the breast of lactating woman.

Source page: https://510kreport.com/device/K093145
Methodology: https://510kreport.com/methodology