510(k) · Cleared
Recalled · Class II · 2026Hydrophilic Silicone Foley Catheter and Personal Catheter (Hydrophilic and Non-Hydrophilic)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rochester Medical Corp. · KOD Catheter, Urological
Cleared on May 19, 2000 after a 74-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it. It has been recalled 26 times.
- Decided
- May 19, 2000
- Review
- 74 days
- Class
- Class II
- Product code
- KOD
- Recalls
- 26
- Predicates
- 0
11 later devices descend from it, 4 citing it directly.
- This deviceK000723 Hydrophilic Silicone Foley Catheter and Personal Catheter…Rochester Medical Corp. · 2000
- Descendant · cites it directly · 6 of its ownK070508 Bardex Lubri-Sil All-Silicone Lubricious Coated Foley Catheter 6 FRC.R. Bard, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 4 of its ownK091699 Amsure Hydrophilic Latex Foley CatheterAmsino International, Inc. · 2009
- Descendant · 3 generations on · 2 of its ownK162989 Rusch Simplastic Foley CathetersTeleflexmedical, Inc. · 2017
- Descendant · cites it directly · 2 of its ownK122785 Hydrosil; Magic; Personal CatheterRochester Medical Corp. · 2013 · Recalled
- Descendant · 4 generations on · 1 of its ownK212077 Teleflex Rusch SoftSimplastic Foley CathetersTeleflexmedical, Inc. · 2023
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
2004high 2 (2017) · low 0 (2005)2026
Most influential descendants
Showing 5 of 11 · See all- K070508Bardex Lubri-Sil All-Silicone Lubricious Coated Foley Catheter 6 FRC.R. Bard, Inc. · 2007 · cites it directly6descendants
- K091699Amsure Hydrophilic Latex Foley CatheterAmsino International, Inc. · 2009 · 2 generations on4descendants
- K162989Rusch Simplastic Foley CathetersTeleflexmedical, Inc. · 2017 · 3 generations on2descendants
- K122785Hydrosil; Magic; Personal CatheterRochester Medical Corp. · 2013 · cites it directly2descendants
- K212077Teleflex Rusch SoftSimplastic Foley CathetersTeleflexmedical, Inc. · 2023 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000723 | Hydrophilic Silicone Foley Catheter and Personal Catheter (Hydrophilic and… | Rochester Medical Corp. | 2000 | — |
| +1 | 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 | — |
| +3 | K162989 | Rusch Simplastic Foley Catheters | Teleflexmedical, Inc. | 2017 | — |
| +1 | K122785 | Hydrosil; Magic; Personal Catheter | Rochester Medical Corp. | 2013 | 3 |
| +4 | K212077 | Teleflex Rusch SoftSimplastic Foley Catheters | Teleflexmedical, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 KOD? 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 KOD device
- #1 K251864 Rubber Utility Catheterscore 10.9 · 1 generation · 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? (11)
See all 114 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070508 | Bardex Lubri-Sil All-Silicone Lubricious Coated Foley Catheter 6 FR | 2007 | 6 |
| K122785 | Hydrosil; Magic; Personal Catheter | 2013 | 2 |
| K172247 | Magic3 Go Intermittent Urinary Catheter | 2017 | 0 |
| K033477 | Hydrophilic-Antibacterial Intermittent Catheter, Intermittent Catheter Closed System Kit | 2004 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 25, 2026 | Class II | Z-3117-2026 | Under Investigation by firm | Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays. |
| Jan 27, 2022 | Class II | Z-0666-2022 | Under Investigation by firm | There is a potential to leak from the catheter where it connects to the drain bag |
| Jan 27, 2022 | Class II | Z-0667-2022 | Under Investigation by firm | There is a potential to leak from the catheter where it connects to the drain bag |
| Sep 14, 2017 | Class II | Z-1307-2018 | Process control | Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed. |
| Sep 14, 2017 | Class II | Z-1308-2018 | Process control | Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed. |
| Sep 14, 2017 | Class II | Z-1309-2018 | Process control | Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed. |
| Aug 24, 2015 | Class II | Z-2732-2015 | Unknown/Undetermined by firm | Potential breach of the sterile barrier packaging. |
| Jul 7, 2015 | Class II | Z-2385-2015 | Unknown/Undetermined by firm | Potential breach of the sterile barrier packaging. |
| Jul 7, 2015 | Class II | Z-2384-2015 | Unknown/Undetermined by firm | Potential breach of the sterile barrier packaging. |
| Jul 7, 2015 | Class II | Z-2386-2015 | Unknown/Undetermined by firm | Potential breach of the sterile barrier packaging. |
| Jul 7, 2015 | Class II | Z-2387-2015 | Unknown/Undetermined by firm | Potential breach of the sterile barrier packaging. |
| Jul 7, 2015 | Class II | Z-2388-2015 | Unknown/Undetermined by firm | Potential breach of the sterile barrier packaging. |
| Jan 14, 2009 | Not classified | Z-1086-2009 | Package design/selection | Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process. |
| Jan 14, 2009 | Not classified | Z-1087-2009 | Package design/selection | Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process. |
| Jan 14, 2009 | Not classified | Z-1077-2009 | Package design/selection | Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process. |
| Jan 14, 2009 | Not classified | Z-1076-2009 | Package design/selection | Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process. |
| Jan 14, 2009 | Not classified | Z-1081-2009 | Package design/selection | Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process. |
| Jan 14, 2009 | Not classified | Z-1083-2009 | Package design/selection | Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process. |
| Jan 14, 2009 | Not classified | Z-1080-2009 | Package design/selection | Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process. |
| Jan 14, 2009 | Not classified | Z-1074-2009 | Package design/selection | Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process. |
| Jan 14, 2009 | Not classified | Z-1085-2009 | Package design/selection | Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process. |
| Jan 14, 2009 | Not classified | Z-1075-2009 | Package design/selection | Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process. |
| Jan 14, 2009 | Not classified | Z-1082-2009 | Package design/selection | Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process. |
| Jan 14, 2009 | Not classified | Z-1078-2009 | Package design/selection | Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process. |
| Jan 14, 2009 | Not classified | Z-1084-2009 | Package design/selection | Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process. |
| Jan 14, 2009 | Not classified | Z-1079-2009 | Package design/selection | Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process. |
The 5 latest of 26 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K070508 (C.R. Bard, Inc., 2007) has gone furthest, with 6 descendants of its own.
How does its category compare?
All KOD devicesKOD Catheter, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KOD
2in 2022
2007high 6 (2018) · low 0 (2007)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · KOD
251in 2018
2007high 251 (2018)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KOD
1in 2023
2007high 47 (2011) · low 0 (2007)2026
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KOD
1,389in 2025
2007high 1,873 (2017) · low 102 (2008)2025
MAUDE reports naming product code KOD, 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 | 0 | — | 0 | 180 |
| 2008 | 2 | — | 0 | 102 |
| 2009 | 1 | — | 15 | 183 |
| 2010 | 1 | — | 1 | 228 |
| 2011 | 2 | — | 47 | 209 |
| 2012 | 0 | — | 2 | 165 |
| 2013 | 0 | — | 0 | 393 |
| 2014 | 1 | — | 0 | 226 |
| 2015 | 0 | — | 0 | 418 |
| 2016 | 2 | — | 1 | 284 |
| 2017 | 1 | — | 0 | 1,873 |
| 2018 | 6 | 251 | 0 | 1,179 |
| 2019 | 1 | — | 1 | 1,167 |
| 2020 | 0 | — | 0 | 1,370 |
| 2021 | 1 | — | 0 | 1,388 |
| 2022 | 2 | — | 3 | 1,280 |
| 2023 | 0 | — | 1 (1) | 1,160 |
| 2024 | 0 | — | 0 | 1,259 |
| 2025 | 0 | — | 0 | 1,389 |
| 2026 | 1 | — | 1 | — |
https://510kreport.com/device/K000723 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000723: Hydrophilic Silicone Foley Catheter and Personal Catheter (Hydrophilic and Non-Hydrophilic).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000723
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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