510(k) · Cleared
Recalled · Class II · 2021Catheter, Silicone Foley (Bardex)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · GBM Catheter, Urethral
Cleared on Aug 23, 1976 after a 63-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it. It has been recalled once.
- Decided
- Aug 23, 1976
- Review
- 63 days
- Class
- Class II
- Product code
- GBM
- Recalls
- 1
- Predicates
- 0
6 later devices descend from it, 4 citing it directly.
- This deviceK760093 Catheter, Silicone Foley (Bardex)C.R. Bard, Inc. · 1976
- Descendant · cites it directly · 5 of its ownK961697 Opticon Female Urinary Incontinence Catheter for Continuous DrainageMedical Device Intl., Inc. · 1996
- Descendant · cites it directly · 3 of its ownK023090 Option-VF Urinary Catheter, FV14218Opticon Medical, Inc. · 2003 · Recalled
- Descendant · cites it directly · 2 of its ownK033830 Option-VF Urinary Catheter with Adaptor, Model FVA14218; Option-V…Opticon Medical, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK041983 Option-VM Urinary Catheter/Adpater, Models MV39016, MVA39016Opticon Medical · 2004 · Recalled
- Descendant · 2 generations on · 0 of its ownK062240 CareventChief Medical, LLC · 2006
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K961697Opticon Female Urinary Incontinence Catheter for Continuous DrainageMedical Device Intl., Inc. · 1996 · cites it directly5descendants
- K023090Option-VF Urinary Catheter, FV14218Opticon Medical, Inc. · 2003 · cites it directly3descendants
- K033830Option-VF Urinary Catheter with Adaptor, Model FVA14218; Option-V Continuous Drainage…Opticon Medical, Inc. · 2004 · cites it directly2descendants
- K041983Option-VM Urinary Catheter/Adpater, Models MV39016, MVA39016Opticon Medical · 2004 · cites it directly1descendant
- K062240CareventChief Medical, LLC · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K760093 | Catheter, Silicone Foley (Bardex) | C.R. Bard, Inc. | 1976 | — |
| +1 | K961697 | Opticon Female Urinary Incontinence Catheter for Continuous Drainage | Medical Device Intl., Inc. | 1996 | — |
| +1 | K023090 | Option-VF Urinary Catheter, FV14218 | Opticon Medical, Inc. | 2003 | 1 |
| +1 | K033830 | Option-VF Urinary Catheter with Adaptor, Model FVA14218; Option-V Continuous… | Opticon Medical, Inc. | 2004 | — |
| +1 | K041983 | Option-VM Urinary Catheter/Adpater, Models MV39016, MVA39016 | Opticon Medical | 2004 | 1 |
| +2 | K062240 | Carevent | Chief Medical, LLC | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GBM? 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 GBM device
- #1 K241734 Wellead® Hydrophilic Intermittent Catheter…score 10.2 · 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K961697 | Opticon Female Urinary Incontinence Catheter for Continuous Drainage | 1996 | 5 |
| K023090 | Option-VF Urinary Catheter, FV14218 | 2003 | 3 |
| K033830 | Option-VF Urinary Catheter with Adaptor, Model FVA14218; Option-V Continuous Drainage… | 2004 | 2 |
| K041983 | Option-VM Urinary Catheter/Adpater, Models MV39016, MVA39016 | 2004 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 5, 2021 | Class II | Z-2533-2021 | Packaging change control | There is potential for packaging defects that may impact the sterile barrier. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K961697 (Medical Device Intl., Inc., 1996) has gone furthest, with 5 descendants of its own.
How does its category compare?
All GBM devicesGBM Catheter, Urethral: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GBM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GBM
230in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GBM
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GBM
311in 2025
MAUDE reports naming product code GBM, 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 | 2 | — | 0 | 5 |
| 2008 | 0 | — | 5 | 18 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 33 |
| 2011 | 2 | — | 1 | 46 |
| 2012 | 3 | 139 | 0 | 32 |
| 2013 | 0 | — | 0 | 41 |
| 2014 | 1 | — | 0 | 19 |
| 2015 | 5 | 76 | 0 | 21 |
| 2016 | 3 | 112 | 0 | 49 |
| 2017 | 2 | — | 0 | 59 |
| 2018 | 6 | 93 | 0 | 82 |
| 2019 | 7 | 121 | 0 | 148 |
| 2020 | 6 | 230 | 0 | 144 |
| 2021 | 0 | — | 0 | 102 |
| 2022 | 2 | — | 0 | 283 |
| 2023 | 0 | — | 1 (1) | 202 |
| 2024 | 0 | — | 0 | 468 |
| 2025 | 1 | — | 1 | 311 |
| 2026 | 0 | — | 1 | — |
https://510kreport.com/device/K760093 · printed Nov 6, 2026
Cite this page
510(k) Report. “K760093: Catheter, Silicone Foley (Bardex).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K760093
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026