# K123751: Lofric Sense

- Pathway: 510(k) (Traditional)
- Applicant: Wellspect Healthcare
- Decided: Feb 28, 2013 after 84 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K2122078: Astra Tech, LoFric Primo. Number could not be read Summary page 2.

## Most influential descendants
- K211212: LoFric Elle (2022), 1 descendant of its own
- K260999: LoFric Elle Pro (2026), 0 descendants of its own

## Indications for use
Intermittent urinary catheterization.

Source page: https://510kreport.com/device/K123751
Methodology: https://510kreport.com/methodology