# K150476: Spectra S1Plus and Spectra S2 Plus

- Pathway: 510(k) (Traditional)
- Applicant: Uzinmedicare Co.
- Decided: Apr 15, 2016 after 416 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 K850705 (1985). 7 ancestors in all.
24 later devices descend from it; 6 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051926: Limerick PJ'S Comfort JR Portable Electric Breast Pump, Limerick, Inc. (2005) Summary page 5.

## Most influential descendants
- K181784: Spectra S3 Plus (2018), 7 descendants of its own
- K180075: MINUET LCD, MINUET LCD eco (2018), 6 descendants of its own
- K190810: OPERA, OPERA eco (2019), 5 descendants of its own
- K162870: CIMLRE F1 and CIMILRE S3 (2017), 4 descendants of its own
- K201152: Electric Breast Pump (2021), 2 descendants of its own

## Indications for use
The Spectra ST Plus and Spectra S2 Plus are single-user, powered breast pumps intended to express and collect milk from the breasts of lactating women.

Source page: https://510kreport.com/device/K150476
Methodology: https://510kreport.com/methodology