# K231785: Perifit Pump

- Pathway: 510(k) (Traditional)
- Applicant: X6 Innovations
- Decided: Jan 26, 2024 after 220 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: 8 generations back to K801862 (1980). 12 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210936: Elvie Stride, Chiaro Technology Limited (2021) Summary page 5.

## Most influential descendants
- K251977: electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X) (2025), 0 descendants of its own
- K250207: eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03) (2025), 0 descendants of its own

## Indications for use
The Perifit Pump is a wearable electric breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

Source page: https://510kreport.com/device/K231785
Methodology: https://510kreport.com/methodology