# K160511: Naya Breast Pump System

- Pathway: 510(k) (Traditional)
- Applicant: Naya Health, Inc.
- Decided: Jun 24, 2016 after 121 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.
2 later devices descend from it; 2 cite 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)
- 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 4.

## Most influential descendants
- K173699: The Pump by Babyation (2018), 0 descendants of its own
- K162747: Proture Double Electric Breast Pump (2016), 0 descendants of its own

## Indications for use
The Naya Breast Pump System is a powered breast pump to be used by lactating women in the hospital or home setting to express and collect milk from their breasts.

Source page: https://510kreport.com/device/K160511
Methodology: https://510kreport.com/methodology