# K250659: LoFric Origo

- Pathway: 510(k) (Traditional)
- Applicant: Wellspect AB
- Decided: Sep 26, 2025 after 205 days
- Product code: EZD (Catheter, Straight)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K896750 (1990). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122078: Lofric Primo, Lofric Hydro-Kit, Astra Tech, Inc. (2012) Summary page 5.

## Most influential descendants
- K261658: LoFric Origo Pro Coudé (2026), 0 descendants of its own

## Indications for use
LoFric Origo is indicated for short- and long-term bladder management with intermittent urinary catheterization.

Source page: https://510kreport.com/device/K250659
Methodology: https://510kreport.com/methodology