# K043241: Lofric Hydro-Kit II Single Use Urinary Catheter

- Pathway: 510(k) (Special)
- Applicant: Astra Tech, Inc.
- Decided: Dec 23, 2004 after 30 days
- Product code: GBM (Catheter, Urethral)
- 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.
9 later devices descend from it; 2 cite it directly.
0 of 11 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 1.

## Most influential descendants
- K062444: HI-Slip and HI-Slip Plus Single Use Hydrophilic Urinary Catheters and Kit (2007), 5 descendants of its own
- K133615: Well Lead PVC Hydrophilic Urethral Catheter (2014), 2 descendants of its own
- 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
The LoFric® Hydro-Kit II Single Use Urinary Catheter is intended for intermittent catheterization of the urethra.

Source page: https://510kreport.com/device/K043241
Methodology: https://510kreport.com/methodology