# K162415: Spectra 9Plus

- Pathway: 510(k) (Traditional)
- Applicant: Uzinmedicare Company
- Decided: Mar 15, 2017 after 198 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 K801862 (1980). 8 ancestors in all.
32 later devices descend from it; 2 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092783: DEBP, Enko, Ltd. (2009) Summary page 4.

## Most influential descendants
- K163136: Youha electric breast pump (2017), 30 descendants of its own
- K201903: Electric breast pump (Models: RH-228 and RH-338) (2021), 21 descendants of its own
- K222782: Wearable Breast Pump (Model:YD-1193,YD-1195,YD-1196,YD-1198,YD-1199;YD-1193S,YD-1195S,YD-1196S,YD-1198S,YD-1199S) (2023), 14 descendants of its own
- K232466: Electric Breast Pump, model: YM-8166 (2024), 12 descendants of its own
- K241322: Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010) (2024), 11 descendants of its own

## Indications for use
The Spectra 9Plus is a single user, powered breast pump intended to express and collect milk from the breasts of lactating women.

Source page: https://510kreport.com/device/K162415
Methodology: https://510kreport.com/methodology