# K061013: Playtex Embrace Petite Breast Pump

- Pathway: 510(k) (Traditional)
- Applicant: Playtex Products, Inc.
- Decided: Aug 15, 2006 after 124 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: 3 generations back to K875300 (1988). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022594: Playtex Breast Pump, Playtex Products, Inc. (2002) Summary page 1.
- K950531: Egnell Elite, Hollister, Inc. (1995) Summary page 1.
- K950750: Medelas Breast Pump, Medela, Inc. (1995) Summary page 1.
- K973501: Expresse and Premier Powered Breast Pumps, Ameda Medizintechnik AG (1997) Summary page 2.

## Most influential descendants
- K093145: Spectra Series Breast Pump (2010), 0 descendants of its own

## Recalls of this device
- Mar 18, 2014 · Class II · Z-1336-2014: Some of the power adapters outer casings may become loose and separate, resulting in a potential for electric shock.

## Indications for use
An electrically powered breast pump used to express milk from the breast of a lactating woman.

Source page: https://510kreport.com/device/K061013
Methodology: https://510kreport.com/methodology