510(k) · Cleared
ClearedTeleflex Rusch SoftSimplastic Foley Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflexmedical, Inc. · EZL Catheter, Retention Type, Balloon
Cleared on Jul 27, 2023 as substantially equivalent to K162989 (Teleflexmedical, Inc., 2017) after a 755-day review. Its family tree reaches back 4 generations to 1999. 1 later device descends from it.
- Decided
- Jul 27, 2023
- Review
- 755 days
- Class
- Class II
- Product code
- EZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K984084 (1999). 10 ancestors in all, the oldest K851684 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK984084 Bardex Lubri-Sil Foley CatheterBard Medical Div. · 1999 · Recalled
- 3 generations backK070508 Bardex Lubri-Sil All-Silicone Lubricious Coated Foley Catheter 6 FRC.R. Bard, Inc. · 2007 · Recalled
- 2 generations backK091699 Amsure Hydrophilic Latex Foley CatheterAmsino International, Inc. · 2009
- 1 generation backK162989 Rusch Simplastic Foley CathetersTeleflexmedical, Inc. · 2017
- This deviceK212077 Teleflex Rusch SoftSimplastic Foley CathetersTeleflexmedical, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK252537 Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K252537Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K984084 | Bardex Lubri-Sil Foley Catheter | Bard Medical Div. | 1999 | 1 |
| −3 | K070508 | Bardex Lubri-Sil All-Silicone Lubricious Coated Foley Catheter 6 FR | C.R. Bard, Inc. | 2007 | 1 |
| −2 | K091699 | Amsure Hydrophilic Latex Foley Catheter | Amsino International, Inc. | 2009 | — |
| −1 | K162989 | Rusch Simplastic Foley Catheters | Teleflexmedical, Inc. | 2017 | — |
| 0 (this device) | K212077 | Teleflex Rusch SoftSimplastic Foley Catheters | Teleflexmedical, Inc. | 2023 | — |
| +1 | K252537 | Rusch SoftSimplastic Foley Catheters | Teleflex Medical Sdn. Bhd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K162989 | Rusch Simplastic Foley CathetersSummary page 4…and Accessories Regulation Number: 21 CFR 876.5130 Product Code: EZL Device Class: Class II Predicate Device K162989, Rusch Simplastic Foley Catheters. This predicate device has not been subject to a design-related… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252537 | Rusch SoftSimplastic Foley Catheters | 2026 | 0 |
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?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 7.5 years on median.
- 4 of the 10 ancestors have a recall of any class.
- Of its descendants, K252537 (Teleflex Medical Sdn. Bhd., 2026) has gone furthest, with 0 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. 2023, 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?
2 Way SoftSimplastic Catheters:
Indicated where routine transurethral drainage of the bladder is required either postoperatively or for patients with conditions requiring transurethral urine drainage.
3 Way SoftSimplastic Catheters:
Indicated where routine transurethral drainage of the bladder is required either postoperatively, for patients with conditions requiring transurethral urine drainage and for patients requiring bladder irrigation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212077 · printed Nov 5, 2026
Cite this page
510(k) Report. “K212077: Teleflex Rusch SoftSimplastic Foley Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K212077
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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