510(k) · Cleared
ClearedDirectvision Catheter, Uncoated
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Percuvision · EZL Catheter, Retention Type, Balloon
Cleared on May 27, 2011 as substantially equivalent to K090262 (Percuvision, LLC, 2009) and 1 other predicate after a 122-day review. Its family tree reaches back 2 generations to 1986. 1 of the 4 devices in its family, counting itself, has a Class I recall.
- Decided
- May 27, 2011
- Review
- 122 days
- Class
- Class II
- Product code
- EZL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K860484 (1986). 3 ancestors in all. No later device cites it as a predicate yet. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK860484 Curity & Kenguard Silicone Coated Foley CatheterThe Kendal Co. · 1986 · Recalled (Class I)
- 1 generation backK090262 Percucath Urinary CatheterPercuvision, LLC · 2009
- This deviceK110214 Directvision Catheter, UncoatedPercuvision · 2011
Class I recalls in this family
- K860484 Curity & Kenguard Silicone Coated Foley Catheterdirect predicate · 1986
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K860484 | Curity & Kenguard Silicone Coated Foley Catheter | The Kendal Co. | 1986 | Class I |
| −1 | K090262 | Percucath Urinary Catheter | Percuvision, LLC | 2009 | — |
| 0 (this device) | K110214 | Directvision Catheter, Uncoated | Percuvision | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 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.
1 device in this family has a Class I recall. 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 EZL device
- #1 K260756 TraumaGuard Intra-Abdominal Pressure-Sensing…score 13.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K090262 | Percucath Urinary CatheterSummary page 1…ce Class: 21 CFR 876.5130 Urological Catheter and Accessories, Class 11 Product Code EZL (Catheter, Retention Type, Balloon) C) Predicate: K090262 PerduCath TM Urinary Catheter (with lubricious coating) K860484 Dover Foley Catheter D) Device Descript… | 2009 |
| * | K860484 | Curity & Kenguard Silicone Coated Foley CatheterSummary page 1…duct Code EZL (Catheter, Retention Type, Balloon) C) Predicate: K090262 PerduCath TM Urinary Catheter (with lubricious coating) K860484 Dover Foley Catheter D) Device Description: The DirectVision® Catheter Uncoated is a flexible tubular device that is inserted… | 1986 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K860484Curity & Kenguard Silicone Coated Foley CatheterThe Kendal Co. · 1986 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 23.2 years on median.
- 1 of the 3 ancestors has a recall of any class; 1 has a Class I recall.
How does its category compare?
All EZL devicesEZL Catheter, Retention Type, Balloon: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · EZL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EZL
123in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EZL
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · EZL
1,381in 2025
MAUDE reports naming product code EZL, 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 | 7 | 186 | 0 | 8 |
| 2008 | 2 | — | 0 | 6 |
| 2009 | 4 | 114 | 0 | 6 |
| 2010 | 1 | — | 0 | 27 |
| 2011 | 2 | — | 0 | 79 |
| 2012 | 0 | — | 0 | 65 |
| 2013 | 3 | 151 | 0 | 99 |
| 2014 | 2 | — | 0 | 229 |
| 2015 | 3 | 132 | 0 | 303 |
| 2016 | 1 | — | 0 | 326 |
| 2017 | 2 | — | 0 | 571 |
| 2018 | 9 | 177 | 0 | 677 |
| 2019 | 3 | 266 | 1 | 671 |
| 2020 | 4 | 137 | 0 | 712 |
| 2021 | 2 | — | 0 | 702 |
| 2022 | 2 | — | 0 | 884 |
| 2023 | 3 | 282 | 2 (2) | 772 |
| 2024 | 5 | 123 | 2 | 1,029 |
| 2025 | 1 | — | 0 | 1,381 |
| 2026 | 4 | 170 | 2 | — |
What is it indicated for?
The DirectVision® Catheter, Uncoated is indicated for use in the drainage and/or collection and/or measurement of urine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110214 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110214: Directvision Catheter, Uncoated.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110214
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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