510(k) · Cleared
ClearedHI-Slip and HI-Slip Plus Single Use Hydrophilic Urinary Catheters and Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oasis Medikal Urunler Kimya Sanayi VE Tic A.S. · EZD Catheter, Straight
Cleared on Feb 22, 2007 as substantially equivalent to K896750 (Astra Meditec AB, 1990) and 6 other predicates after a 185-day review. Its family tree reaches back 3 generations to 1991. 5 later devices descend from it.
- Decided
- Feb 22, 2007
- Review
- 185 days
- Class
- Class II
- Product code
- EZD
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 3 generations to K910022 (1991). 8 ancestors in all, the oldest K896750 (1990). 5 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK910022 MMG/O'neil Urinary Catheterization System KitMedical Marketing Group · 1991
- 2 generations backK973070 Conveen Easicath SetColoplast Corp. · 1997
- 1 generation backK023254 SpeedicathColoplast Corp. · 2003
- This deviceK062444 HI-Slip and HI-Slip Plus Single Use Hydrophilic Urinary Catheters…Oasis Medikal Urunler Kimya Sanayi VE Tic A.S. · 2007
- Descendant · cites it directly · 2 of its ownK133615 Well Lead PVC Hydrophilic Urethral CatheterWell Lead Medical Co., Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK220722 PVC Hydrophilic Urethral CatheterWell Lead Medical Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK223756 SimPro™ Now, GentleCath™ HydrophilicDentsply Sirona · 2023
- Descendant · cites it directly · 0 of its ownK212567 PVC Hydrophilic Urethral CatheterChengdu Daxan Innovative Medical Tech. Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK142563 Well Lead PVC Urethral CatheterWell Lead Medical Co., Ltd. · 2014
Most influential descendants
Showing 5 of 5 · See all- K133615Well Lead PVC Hydrophilic Urethral CatheterWell Lead Medical Co., Ltd. · 2014 · cites it directly2descendants
- K220722PVC Hydrophilic Urethral CatheterWell Lead Medical Co., Ltd. · 2023 · 2 generations on0descendants
- K223756SimPro™ Now, GentleCath™ HydrophilicDentsply Sirona · 2023 · cites it directly0descendants
- K212567PVC Hydrophilic Urethral CatheterChengdu Daxan Innovative Medical Tech. Co., Ltd. · 2022 · cites it directly0descendants
- K142563Well Lead PVC Urethral CatheterWell Lead Medical Co., Ltd. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K910022 | MMG/O'neil Urinary Catheterization System Kit | Medical Marketing Group | 1991 | — |
| −2 | K973070 | Conveen Easicath Set | Coloplast Corp. | 1997 | — |
| −1 | K023254 | Speedicath | Coloplast Corp. | 2003 | — |
| 0 (this device) | K062444 | HI-Slip and HI-Slip Plus Single Use Hydrophilic Urinary Catheters and Kit | Oasis Medikal Urunler Kimya Sanayi VE Tic A.S. | 2007 | — |
| +1 | K133615 | Well Lead PVC Hydrophilic Urethral Catheter | Well Lead Medical Co., Ltd. | 2014 | — |
| +2 | K220722 | PVC Hydrophilic Urethral Catheter | Well Lead Medical Co., Ltd. | 2023 | — |
| +1 | K223756 | SimPro™ Now, GentleCath™ Hydrophilic | Dentsply Sirona | 2023 | — |
| +1 | K212567 | PVC Hydrophilic Urethral Catheter | Chengdu Daxan Innovative Medical Tech. Co., Ltd. | 2022 | — |
| +2 | K142563 | Well Lead PVC Urethral Catheter | Well Lead Medical Co., Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EZD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EZD device
- #1 K241210 Luja Coudescore 16.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K896750 | Lofric (R), Lofric (R) Cath-KitSummary page 3…friction while inserting the catheter into the urethra. Hi-Slip is substantially equivalent to the following predicate devices: · LoFric®Single Use Urinary Catheter K896750, Astra Tech Inc. · LoFric®Plus Single Use Urinary Catheter KO12374, Astra Tech Inc. * SpeediCath K023254, Coloplast Corp.… | 1990 |
| * | K012374 | Modification to: Lofric Plus Single Use Urinary CatheterSummary page 4…Corp. Catheter Astra Tech Inc.L 510 (k) i K012374 K023254 K896750 number… | 2001 |
| * | K023254 | SpeedicathSummary page 3…predicate devices: · LoFric®Single Use Urinary Catheter K896750, Astra Tech Inc. · LoFric®Plus Single Use Urinary Catheter KO12374, Astra Tech Inc. * SpeediCath K023254, Coloplast Corp. * FloaCath Catheter K000070, ROsch International. Hi-Slip Plus (with water sachet) is substantially equivale… | 2003 |
| * | K000070 | FlocathSummary page 3…y Catheter K896750, Astra Tech Inc. · LoFric®Plus Single Use Urinary Catheter KO12374, Astra Tech Inc. * SpeediCath K023254, Coloplast Corp. * FloaCath Catheter K000070, ROsch International. Hi-Slip Plus (with water sachet) is substantially equivalent to the following predicate devices: · LoFr… | 2000 |
| * | K050874 | Astra Tech AB Lofric Primo Single Use Urinary CatheterSummary page 3…70, ROsch International. Hi-Slip Plus (with water sachet) is substantially equivalent to the following predicate devices: · LoFric® Primo Single Use Urinary Catheter K050874, Astra Tech Inc. * SpeediCath K023254, Coloplast Corp. Hi-Slip Kit (with urine bag, water sachet and povidone Iodine swab) is… | 2005 |
| * | K043241 | Lofric Hydro-Kit II Single Use Urinary CatheterSummary page 3…ine bag, water sachet and povidone Iodine swab) is substantially equivalent to the following predicate devices: · LoFric®Plus Hydro-Kit II Single Use Urinary Catheter K043241, Astra Tech Inc. * EasiCath Set K973070, Coloplast Corp. Branded as the SureCath Set in the US.… | 2004 |
| * | K973070 | Conveen Easicath SetSummary page 3…substantially equivalent to the following predicate devices: · LoFric®Plus Hydro-Kit II Single Use Urinary Catheter K043241, Astra Tech Inc. * EasiCath Set K973070, Coloplast Corp. Branded as the SureCath Set in the US. Section-3, 510(k)… | 1997 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K133615 (Well Lead Medical Co., Ltd., 2014) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K896750.
How does its category compare?
All EZD devicesEZD Catheter, Straight: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · EZD
11so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · EZD
130in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EZD
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EZD
288in 2025
MAUDE reports naming product code EZD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 121 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 4 |
| 2010 | 2 | — | 0 | 6 |
| 2011 | 4 | 116 | 1 | 4 |
| 2012 | 2 | — | 1 | 2 |
| 2013 | 4 | 110 | 0 | 18 |
| 2014 | 5 | 91 | 1 | 17 |
| 2015 | 1 | — | 0 | 21 |
| 2016 | 3 | 83 | 0 | 21 |
| 2017 | 2 | — | 0 | 120 |
| 2018 | 3 | 122 | 0 | 390 |
| 2019 | 0 | — | 0 | 466 |
| 2020 | 1 | — | 0 | 563 |
| 2021 | 0 | — | 0 | 994 |
| 2022 | 10 | 288 | 0 | 487 |
| 2023 | 6 | 214 | 0 | 553 |
| 2024 | 5 | 147 | 0 | 116 |
| 2025 | 6 | 130 | 0 | 288 |
| 2026 | 11 | 146 | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062444 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062444: HI-Slip and HI-Slip Plus Single Use Hydrophilic Urinary Catheters and Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062444
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026