# K181784: Spectra S3 Plus

- Pathway: 510(k) (Traditional)
- Applicant: Uzinmedicare Co.
- Decided: Nov 30, 2018 after 150 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: 5 generations back to K850705 (1985). 8 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150476: Spectra S1Plus and Spectra S2 Plus, Uzinmedicare Co. (2016) Summary page 5.

## Most influential descendants
- K201152: Electric Breast Pump (2021), 2 descendants of its own
- K223084: MilkMate Breast Pump (2023), 1 descendant of its own
- K191208: Spectra Cashmere (2019), 1 descendant of its own
- K241705: MilkMate Breast Pump (A0006); MilkMate Kit (sterile, single-use only), 21 mm breast shield (A0005-21); MilkMate Kit (sterile, single-use only), 24 mm breast shield (A0005-24) (2024), 0 descendants of its own
- K221576: Ameda Pearl Electric Breast Pump (2022), 0 descendants of its own

## Indications for use
The Spectra 3 Plus Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Spectra 3 Plus 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/K181784
Methodology: https://510kreport.com/methodology