510(k) · Cleared
Recalled · Class I · 2023Kendall Ultramer Coude Foley Catheter, Model 1416C, Kendall Curity Coude Foley Catheter Tray, Model 6946C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Kendal Co. · EZL Catheter, Retention Type, Balloon
Cleared on Sep 28, 1999 as substantially equivalent to K910195 (C.R. Bard, Inc., 1991) after a 223-day review. Its family tree reaches back 1 generation to 1991. 1 of the 7 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Sep 28, 1999
- Review
- 223 days
- Class
- Class II
- Product code
- EZL
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 1 generation to K910195 (1991). 5 later devices descend from it, 2 citing it directly. 1 of the 7 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK910195 Bard Hydrogel-Coated Foley CathetersC.R. Bard, Inc. · 1991 · Recalled
- This deviceK990500 Kendall Ultramer Coude Foley Catheter, Model 1416C, Kendall Curity…The Kendal Co. · 1999
- Descendant · cites it directly · 3 of its ownK042110 BeamcathBeampoint AB · 2005
- Descendant · 2 generations on · 1 of its ownK131655 Lighthouse (TM) Urinary CatheterSeedings Life Science Ventures, LLC · 2013
- Descendant · 2 generations on · 0 of its ownK140099 Lighthouse Urinary CatheterSeedings Life Science Ventures, LLC · 2014
- Descendant · 2 generations on · 0 of its ownK082919 UC-Care Positioning SystemUc-Care Medical Systems, Ltd. · 2008
- Descendant · cites it directly · 0 of its ownK061661 Sta Cath Attachable Infision Catheter, Model STA20Advanced Infusion, Inc. · 2006
Most influential descendants
Showing 5 of 5 · See all- K042110BeamcathBeampoint AB · 2005 · cites it directly3descendants
- K131655Lighthouse (TM) Urinary CatheterSeedings Life Science Ventures, LLC · 2013 · 2 generations on1descendant
- K140099Lighthouse Urinary CatheterSeedings Life Science Ventures, LLC · 2014 · 2 generations on0descendants
- K082919UC-Care Positioning SystemUc-Care Medical Systems, Ltd. · 2008 · 2 generations on0descendants
- K061661Sta Cath Attachable Infision Catheter, Model STA20Advanced Infusion, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910195 | Bard Hydrogel-Coated Foley Catheters | C.R. Bard, Inc. | 1991 | 1 |
| 0 (this device) | K990500 | Kendall Ultramer Coude Foley Catheter, Model 1416C, Kendall Curity Coude Foley… | The Kendal Co. | 1999 | — |
| +1 | K042110 | Beamcath | Beampoint AB | 2005 | — |
| +2 | K131655 | Lighthouse (TM) Urinary Catheter | Seedings Life Science Ventures, LLC | 2013 | — |
| +2 | K140099 | Lighthouse Urinary Catheter | Seedings Life Science Ventures, LLC | 2014 | — |
| +2 | K082919 | UC-Care Positioning System | Uc-Care Medical Systems, Ltd. | 2008 | — |
| +1 | K061661 | Sta Cath Attachable Infision Catheter, Model STA20 | Advanced Infusion, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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? (1)
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 |
|---|---|---|---|
| * | K910195 | Bard Hydrogel-Coated Foley CathetersSummary page 1…ame: Coude Foley Catherter Classificaion Name; Urological Catheter and accessories (21 CFR §876.5130(¢h)) Predicaie Device: Bardex Lubricath Coude Foley Catheter 510(k) #K910195 Descriptjon of the Device: The Kendall Ulwamer Coude Foley Catheter is a sterile, single use uralagical catheter composed of na… | 1991 |
What descends from it? (5)
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 4, 2023 | Class I | Z-1050-2024 | Nonconforming Material/Component | Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All EZL devicesEZL Catheter, Retention Type, Balloon: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Kendall Coude Foley Catheter is a urological catheter designed with a bent tip to provide transurethral access to the obstructed bladder in the male patient for irrigation and urine drainage.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990500 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990500: Kendall Ultramer Coude Foley Catheter, Model 1416C, Kendall Curity Coude Foley Catheter Tray, Model 6946C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990500
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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