# K113424: Lofric Single Use Urinary Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Astra Tech AB
- Decided: Apr 17, 2012 after 148 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: 1 generation back to K896750 (1990). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K896750: Lofric (R), Lofric (R) Cath-Kit, Astra Meditec AB (1990) Summary page 2.

## Most influential descendants
- K122078: Lofric Primo, Lofric Hydro-Kit (2012), 2 descendants of its own
- K250659: LoFric Origo (2025), 1 descendant of its own
- K261658: LoFric Origo Pro Coudé (2026), 0 descendants of its own

## Indications for use
LoFric® Single Use Urinary Catheter is intended for intermittent urinary catheterization.

Source page: https://510kreport.com/device/K113424
Methodology: https://510kreport.com/methodology