# K161725: Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail

- Pathway: 510(k) (Traditional)
- Applicant: Medela, Inc.
- Decided: Oct 28, 2016 after 128 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: 3 generations back to K801862 (1980). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151632: Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental, Medela AG (2015) Summary page 5.

## Indications for use
The Sonata breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Sonata breast pump is intended for a single user.

Source page: https://510kreport.com/device/K161725
Methodology: https://510kreport.com/methodology