# K122078: Lofric Primo, Lofric Hydro-Kit

- Pathway: 510(k) (Traditional)
- Applicant: Astra Tech, Inc.
- Decided: Oct 31, 2012 after 107 days
- Product code: EZD (Catheter, Straight)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K896750 (1990). 4 ancestors in all.
2 later devices descend 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)
- K113424: Lofric Single Use Urinary Catheter, Astra Tech AB (2012)
- K043241: Lofric Hydro-Kit II Single Use Urinary Catheter, Astra Tech, Inc. (2004) Summary page 2.
- K050874: Astra Tech AB Lofric Primo Single Use Urinary Catheter, Astra Tech, Inc. (2005) Summary page 2.

## Most influential descendants
- K250659: LoFric Origo (2025), 1 descendant of its own
- K261658: LoFric Origo Pro Coudé (2026), 0 descendants of its own

## Recalls of this device
- Jun 17, 2020 · Class II · Z-2643-2020: Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo" urethral catheters due to a potential defect which may be present in the catheter s distal tip.
- Jun 17, 2020 · Class II · Z-2644-2020: Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo" urethral catheters due to a potential defect which may be present in the catheters distal tip.
- Jun 17, 2020 · Class II · Z-2645-2020: Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo" urethral catheters due to a potential defect which may be present in the catheters distal tip.

## Indications for use
LoFric® PrimoTM and LoFric® Hydro-KitTm are intended for intermittent urinary catheterization.

Source page: https://510kreport.com/device/K122078
Methodology: https://510kreport.com/methodology