# K250208: SPECTRA Wearable 2

- Pathway: 510(k) (Traditional)
- Applicant: Uzinmedicare Co., Ltd.
- Decided: Apr 6, 2026 after 437 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: 9 generations back to K801862 (1980). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220926: Spectra Wearable, Uzinmedicare Co., Ltd. (2022) Summary page 5.

## Indications for use
The SPECTRA Wearable 2 is a powered breast pump to be used by lactating women to stimulate, express and collect milk from their breasts. The SPECTRA Wearable 2 is intended for home use by a single user.

Source page: https://510kreport.com/device/K250208
Methodology: https://510kreport.com/methodology