510(k) · Cleared
ClearedRusch Simplastic Councill Tip Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rusch, Inc. · EZL Catheter, Retention Type, Balloon
Cleared on Jan 27, 1998 after a 64-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Jan 27, 1998
- Review
- 64 days
- Class
- Class II
- Product code
- EZL
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK974419 Rusch Simplastic Councill Tip CatheterRusch, Inc. · 1998
- 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
Most influential descendants
Showing 4 of 4 · 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974419 | Rusch Simplastic Councill Tip Catheter | Rusch, Inc. | 1998 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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.
Planning a device in EZL? 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 |
|---|---|---|---|
| * | — | Porges Graham® Catheter Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042110 | Beamcath | 2005 | 3 |
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?
- Of its descendants, K042110 (Beampoint AB, 2005) has gone furthest, with 3 descendants of its own.
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 Device is intended for placement of the Foley catheter in the bladder
for drainage when there is difficulty in negotiating the urethra
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/K974419 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974419: Rusch Simplastic Councill Tip Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974419
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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