510(k) · Cleared
Recalled · Class II · 2026Hydrogel-Coated Urethral Catheters and Drains
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · EZC Catheter, Coude
Cleared on Aug 9, 1991 after a 205-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled once.
- Decided
- Aug 9, 1991
- Review
- 205 days
- Class
- Class II
- Product code
- EZC
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK910197 Hydrogel-Coated Urethral Catheters and DrainsC.R. Bard, Inc. · 1991
- Descendant · cites it directly · 2 of its ownK070879 Bard Malecot and Pezzer DrainsC.R. Bard, Inc. · 2007
- Descendant · 2 generations on · 1 of its ownK101900 Hakki Urinary Catheter; Size 14, 16, 18, 20, 22, 24, 26 FrenchHakki Medical Technologies, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK191512 LotusCatheter (Lotus No Balloon Catheter)Hakki Medical Technologies, Inc. · 2020
Most influential descendants
Showing 3 of 3 · See all- K070879Bard Malecot and Pezzer DrainsC.R. Bard, Inc. · 2007 · cites it directly2descendants
- K101900Hakki Urinary Catheter; Size 14, 16, 18, 20, 22, 24, 26 FrenchHakki Medical Technologies, Inc. · 2011 · 2 generations on1descendant
- K191512LotusCatheter (Lotus No Balloon Catheter)Hakki Medical Technologies, Inc. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K910197 | Hydrogel-Coated Urethral Catheters and Drains | C.R. Bard, Inc. | 1991 | — |
| +1 | K070879 | Bard Malecot and Pezzer Drains | C.R. Bard, Inc. | 2007 | — |
| +2 | K101900 | Hakki Urinary Catheter; Size 14, 16, 18, 20, 22, 24, 26 French | Hakki Medical Technologies, Inc. | 2011 | — |
| +2 | K191512 | LotusCatheter (Lotus No Balloon Catheter) | Hakki Medical Technologies, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EZC? 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 EZC device
- #1 K222279 Rusch Intermittent Urethral Cathetersscore 3.9 · 1 generation · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070879 | Bard Malecot and Pezzer Drains | 2007 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 25, 2026 | Class II | Z-3114-2026 | Under Investigation by firm | Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K070879 (C.R. Bard, Inc., 2007) has gone furthest, with 2 descendants of its own.
How does its category compare?
All EZC devicesEZC Catheter, Coude: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EZC
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · EZC
Too few EZC 510(k)s in any year since 2007 to give a median.
Recalls per year · EZC
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EZC
1,213in 2025
MAUDE reports naming product code EZC, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 14 |
| 2015 | 0 | — | 0 | 20 |
| 2016 | 0 | — | 0 | 170 |
| 2017 | 0 | — | 0 | 963 |
| 2018 | 1 | — | 0 | 886 |
| 2019 | 0 | — | 0 | 1,000 |
| 2020 | 0 | — | 0 | 1,027 |
| 2021 | 0 | — | 0 | 1,030 |
| 2022 | 1 | — | 0 | 1,365 |
| 2023 | 0 | — | 0 | 1,142 |
| 2024 | 0 | — | 0 | 957 |
| 2025 | 0 | — | 0 | 1,213 |
| 2026 | 0 | — | 1 | — |
https://510kreport.com/device/K910197 · printed Nov 6, 2026
Cite this page
510(k) Report. “K910197: Hydrogel-Coated Urethral Catheters and Drains.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K910197
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026