# K221576: Ameda Pearl Electric Breast Pump

- Pathway: 510(k) (Traditional)
- Applicant: Ameda, Inc.
- Decided: Oct 12, 2022 after 133 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: 6 generations back to K850705 (1985). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181784: Spectra S3 Plus, Uzinmedicare Co. (2018) Summary page 4.

## Indications for use
The Ameda Pearl Electric Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Ameda Pearl Electric Breast Pump is intended for multiple users in a hospital setting. It is also intended for home use by a single user.

Source page: https://510kreport.com/device/K221576
Methodology: https://510kreport.com/methodology