510(k) · Cleared
Recalled · Class II · 2022Rusch MMG/O'neil Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rusch, Inc. · FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Cleared on May 9, 2001 after an 86-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 32 later devices descend from it. It has been recalled 3 times.
- Decided
- May 9, 2001
- Review
- 86 days
- Class
- Class II
- Product code
- FCM
- Recalls
- 3
- Predicates
- 0
32 later devices descend from it, 3 citing it directly.
- This deviceK010420 Rusch MMG/O'neil CatheterRusch, Inc. · 2001
- Descendant · cites it directly · 20 of its ownK013483 Incare Advance; Intermittent Catheter, Plus Intermittent Catheter…Hollister, Inc. · 2002
- Descendant · 2 generations on · 15 of its ownK090960 Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142…Hollister, Inc. · 2009
- Descendant · 2 generations on · 14 of its ownK110862 Vapro Plus Intermittent CatheterHollister Incorporated · 2011
- Descendant · 3 generations on · 13 of its ownK141642 Vapro Intermittent CatheterHollister Incorporated · 2014
- Descendant · cites it directly · 10 of its ownK080881 Cure Catheter Closed SystemCure Medical, LLC · 2008
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K013483Incare Advance; Intermittent Catheter, Plus Intermittent Catheter, Plus KitHollister, Inc. · 2002 · cites it directly20descendants
- K090960Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064, 72084…Hollister, Inc. · 2009 · 2 generations on15descendants
- K110862Vapro Plus Intermittent CatheterHollister Incorporated · 2011 · 2 generations on14descendants
- K141642Vapro Intermittent CatheterHollister Incorporated · 2014 · 3 generations on13descendants
- K080881Cure Catheter Closed SystemCure Medical, LLC · 2008 · cites it directly10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010420 | Rusch MMG/O'neil Catheter | Rusch, Inc. | 2001 | — |
| +1 | K013483 | Incare Advance; Intermittent Catheter, Plus Intermittent Catheter, Plus Kit | Hollister, Inc. | 2002 | — |
| +2 | K090960 | Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064… | Hollister, Inc. | 2009 | — |
| +2 | K110862 | Vapro Plus Intermittent Catheter | Hollister Incorporated | 2011 | — |
| +3 | K141642 | Vapro Intermittent Catheter | Hollister Incorporated | 2014 | — |
| +1 | K080881 | Cure Catheter Closed System | Cure Medical, LLC | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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 FCM? 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 FCM device
- #1 K254076 BD Touchless™ Plus Unisex Pre-Lubricated…score 11.4 · 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? (32)
See all 323 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 20, 2022 | Class II | Z-0227-2023 | Nonconforming Material/Component | Product may not be sterile |
| Nov 22, 2016 | Class II | Z-0771-2017 | Error in labeling | Labeling Inconsistency: The products have been labeled with the incorrect expiration date which exceeds the actual, validated 35-month shelf life. |
| Jul 11, 2005 | Not classified | Z-1083-05 | Other | There is a lack of assurance of sterility for parts of these lots of product. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K013483 (Hollister, Inc., 2002) has gone furthest, with 20 descendants of its own.
How does its category compare?
All FCM devicesFCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FCM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FCM
Too few FCM 510(k)s in any year since 2007 to give a median.
Recalls per year · FCM
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FCM
35in 2025
MAUDE reports naming product code FCM, 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 | 1 |
| 2008 | 1 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 6 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 31 | 4 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 0 | — | 0 | 14 |
| 2017 | 0 | — | 0 | 33 |
| 2018 | 0 | — | 0 | 61 |
| 2019 | 0 | — | 0 | 79 |
| 2020 | 0 | — | 0 | 86 |
| 2021 | 0 | — | 0 | 85 |
| 2022 | 0 | — | 6 | 59 |
| 2023 | 1 | — | 1 (1) | 48 |
| 2024 | 0 | — | 0 | 54 |
| 2025 | 1 | — | 0 | 35 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K010420 · printed Nov 5, 2026
Cite this page
510(k) Report. “K010420: Rusch MMG/O'neil Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K010420
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026