510(k) · Cleared
ClearedBardex Lubri-Sil and Bardex Lubri-Sil I.C. Anti-Infective All-Silicone Foley Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · EZL Catheter, Retention Type, Balloon
Cleared on Dec 7, 2007 as substantially equivalent to K002868 (C.R. Bard, Inc., 2000) after a 283-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it.
- Decided
- Dec 7, 2007
- Review
- 283 days
- Class
- Class II
- Product code
- EZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002868 (2000). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK002868 Bard All-Silicone 3-Way Foley Catheter; Bard Lubri-Sil 3-Way Foley…C.R. Bard, Inc. · 2000
- This deviceK070558 Bardex Lubri-Sil and Bardex Lubri-Sil I.C. Anti-Infective…C.R. Bard, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK091767 3 Way Silicone Foley Balloon CatheterCook Urological, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK181616 PSM 3-Way Silicone Foley CatheterPathway, LLC · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002868 | Bard All-Silicone 3-Way Foley Catheter; Bard Lubri-Sil 3-Way Foley Catheter… | C.R. Bard, Inc. | 2000 | — |
| 0 (this device) | K070558 | Bardex Lubri-Sil and Bardex Lubri-Sil I.C. Anti-Infective All-Silicone Foley… | C.R. Bard, Inc. | 2007 | — |
| +1 | K091767 | 3 Way Silicone Foley Balloon Catheter | Cook Urological, Inc. | 2009 | — |
| +2 | K181616 | PSM 3-Way Silicone Foley Catheter | Pathway, LLC | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K002868 | Bard All-Silicone 3-Way Foley Catheter; Bard Lubri-Sil 3-Way Foley Catheter; Bard…Summary page 2…Sil® I.C. 3- Way Foley Catheter referenced in this submission are held to the same design, manufacture, and performance specifications as the predicate (#K002868). Performance and functional testing standards are based on the FDA "Guidance for the Content of Premarket Notifi… | 2000 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091767 | 3 Way Silicone Foley Balloon Catheter | 2009 | 1 |
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. 2007, 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?
The Bardex® Lubri-Sil® All-Silicone Foley Catheter, and the Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter are indicated for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.
Some Foley catheters, especially those with larger (30cc) balloons are used to assist in hemostatis following surgery such as transurethral resection of the prostate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070558 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070558: Bardex Lubri-Sil and Bardex Lubri-Sil I.C. Anti-Infective All-Silicone 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/K070558
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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