510(k) · Cleared
Recalled · Class II · 2017Bard Hydrogel-Coated Foley Catheters
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. 1 of the 9 devices in its family, counting itself, has a Class I recall. 8 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
8 later devices descend from it, 2 citing it directly. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- This deviceK910195 Bard Hydrogel-Coated Foley CathetersC.R. Bard, Inc. · 1991
- Descendant · cites it directly · 5 of its ownK990500 Kendall Ultramer Coude Foley Catheter, Model 1416C, Kendall Curity…The Kendal Co. · 1999 · Recalled (Class I)
- Descendant · 2 generations on · 3 of its ownK042110 BeamcathBeampoint AB · 2005
- Descendant · cites it directly · 1 of its ownK150699 Bard LubriGuard Foley CatheterC.R. Bard, Inc. · 2015
- Descendant · 3 generations on · 1 of its ownK131655 Lighthouse (TM) Urinary CatheterSeedings Life Science Ventures, LLC · 2013
- Descendant · 2 generations on · 0 of its ownK180781 Bard Vertus Foley CatheterC.R. Bard, Inc. · 2018
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K990500 Kendall Ultramer Coude Foley Catheter, Model…cites it directly · 1999
Most influential descendants
Showing 5 of 8 · See all- K990500Kendall Ultramer Coude Foley Catheter, Model 1416C, Kendall Curity Coude Foley Catheter…The Kendal Co. · 1999 · cites it directly5descendants
- K042110BeamcathBeampoint AB · 2005 · 2 generations on3descendants
- K150699Bard LubriGuard Foley CatheterC.R. Bard, Inc. · 2015 · cites it directly1descendant
- K131655Lighthouse (TM) Urinary CatheterSeedings Life Science Ventures, LLC · 2013 · 3 generations on1descendant
- K180781Bard Vertus Foley CatheterC.R. Bard, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K910195 | Bard Hydrogel-Coated Foley Catheters | C.R. Bard, Inc. | 1991 | — |
| +1 | K990500 | Kendall Ultramer Coude Foley Catheter, Model 1416C, Kendall Curity Coude Foley… | The Kendal Co. | 1999 | Class I |
| +2 | K042110 | Beamcath | Beampoint AB | 2005 | — |
| +1 | K150699 | Bard LubriGuard Foley Catheter | C.R. Bard, Inc. | 2015 | — |
| +3 | K131655 | Lighthouse (TM) Urinary Catheter | Seedings Life Science Ventures, LLC | 2013 | — |
| +2 | K180781 | Bard Vertus Foley Catheter | C.R. Bard, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 1 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 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.
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 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? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 13, 2017 | Class II | Z-2064-2018 | Process control | Foley Catheter with Incorrect Retainer Cap Print |
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.
- K990500Kendall Ultramer Coude Foley Catheter, Model 1416C, Kendall Curity Coude Foley Catheter Tray, Model 6946CThe Kendal Co. · 1999 · Cites it directly · ◆ in the 1999 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K990500 (The Kendal Co., 1999) has gone furthest, with 5 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/K910195 · printed Nov 6, 2026
Cite this page
510(k) Report. “K910195: Bard Hydrogel-Coated Foley Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K910195
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026