510(k) · Cleared
ClearedHDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pathway, LLC · EZL Catheter, Retention Type, Balloon
Cleared on Apr 21, 2020 as substantially equivalent to K984084 (Bard Medical Div., 1999) after a 266-day review. Its family tree reaches back 1 generation to 1999. 3 later devices descend from it.
- Decided
- Apr 21, 2020
- Review
- 266 days
- Class
- Class II
- Product code
- EZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K984084 (1999). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK984084 Bardex Lubri-Sil Foley CatheterBard Medical Div. · 1999 · Recalled
- This deviceK192034 HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone…Pathway, LLC · 2020
- Descendant · cites it directly · 2 of its ownK221625 2-Way 100% Silicone ClearTract CatheterSilq Technologies Corporation · 2022
- Descendant · 2 generations on · 1 of its ownK222118 2-Way 100% Silicone Cleartract CatheterSilq Technologies, Corp. · 2022
- Descendant · 3 generations on · 0 of its ownK233013 2-Way 100% Silicone Cleartract CatheterSilq Technologies Corporation · 2024
Most influential descendants
Showing 3 of 3 · See all- K2216252-Way 100% Silicone ClearTract CatheterSilq Technologies Corporation · 2022 · cites it directly2descendants
- K2221182-Way 100% Silicone Cleartract CatheterSilq Technologies, Corp. · 2022 · 2 generations on1descendant
- K2330132-Way 100% Silicone Cleartract CatheterSilq Technologies Corporation · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K984084 | Bardex Lubri-Sil Foley Catheter | Bard Medical Div. | 1999 | 1 |
| 0 (this device) | K192034 | HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way… | Pathway, LLC | 2020 | — |
| +1 | K221625 | 2-Way 100% Silicone ClearTract Catheter | Silq Technologies Corporation | 2022 | — |
| +2 | K222118 | 2-Way 100% Silicone Cleartract Catheter | Silq Technologies, Corp. | 2022 | — |
| +3 | K233013 | 2-Way 100% Silicone Cleartract Catheter | Silq Technologies Corporation | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K984084 | Bardex Lubri-Sil Foley CatheterSummary page 4…876.5130 - Urological catheter and February 1, Bardex Lubi-Sil Foley Catheter EZL K984084 accessories 1999 Device Description The Subject… | 1999 |
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 |
|---|---|---|---|
| K221625 | 2-Way 100% Silicone ClearTract Catheter | 2022 | 2 |
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?
How does its category compare?
All EZL devicesEZL Catheter, Retention Type, Balloon: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Urological catheter is intended for drainage of the urinary tract. Catheterization is accomplished by inserting the catheter through the urethra and into the bladder. Intended population is adults and pediatrics.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192034 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192034: HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192034
Report an extraction error
Are you the manufacturer?
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