# K062444: HI-Slip and HI-Slip Plus Single Use Hydrophilic Urinary Catheters and Kit

- Pathway: 510(k) (Traditional)
- Applicant: Oasis Medikal Urunler Kimya Sanayi VE Tic A.S.
- Decided: Feb 22, 2007 after 185 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 K910022 (1991). 8 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 14 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 3.
- K012374: Modification to: Lofric Plus Single Use Urinary Catheter, Astra Tech, Inc. (2001) Summary page 4.
- K023254: Speedicath, Coloplast Corp. (2003) Summary page 3.
- K000070: Flocath, Rusch Intl. (2000) Summary page 3.
- K050874: Astra Tech AB Lofric Primo Single Use Urinary Catheter, Astra Tech, Inc. (2005) Summary page 3.
- K043241: Lofric Hydro-Kit II Single Use Urinary Catheter, Astra Tech, Inc. (2004) Summary page 3.
- K973070: Conveen Easicath Set, Coloplast Corp. (1997) Summary page 3.

## Most influential descendants
- K133615: Well Lead PVC Hydrophilic Urethral Catheter (2014), 2 descendants of its own
- K220722: PVC Hydrophilic Urethral Catheter (2023), 0 descendants of its own
- K223756: SimPro™ Now, GentleCath™ Hydrophilic (2023), 0 descendants of its own
- K212567: PVC Hydrophilic Urethral Catheter (2022), 0 descendants of its own
- K142563: Well Lead PVC Urethral Catheter (2014), 0 descendants of its own

## Indications for use
Hi-Slip, Hi-Slip Plus and Hi-Slip Kit are launched for Clean Intermittent Catheterization-CIC treatment and is indicated for use by patients with chronic urine retention. The catheter is inserted into the bladder through the urethra for emptying the bladder.

Source page: https://510kreport.com/device/K062444
Methodology: https://510kreport.com/methodology