# K251423: Spectra S1 Pro; Spectra S2 Pro

- Pathway: 510(k) (Traditional)
- Applicant: Uzinmedicare Co., Ltd.
- Decided: Feb 6, 2026 after 274 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.
No later device cites it as a predicate yet.
0 of 9 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.

## Indications for use
The Spectra S1 Pro and Spectra S2 Pro are single-user, powered breast pumps intended to express and collect milk from the breasts of lactating women.

Source page: https://510kreport.com/device/K251423
Methodology: https://510kreport.com/methodology