510(k) · Decided
DecidedMMG/O'neil Urinary Catheterization System Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Marketing Group · FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Cleared on Apr 2, 1991 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 57 later devices descend from it.
- Decided
- Apr 2, 1991
- Review
- 89 days
- Class
- Class II
- Product code
- FCM
- Recalls
- None
- Predicates
- 0
57 later devices descend from it, 2 citing it directly.
- This deviceK910022 MMG/O'neil Urinary Catheterization System KitMedical Marketing Group · 1991
- Descendant · cites it directly · 55 of its ownK973070 Conveen Easicath SetColoplast Corp. · 1997
- Descendant · 2 generations on · 53 of its ownK023254 SpeedicathColoplast Corp. · 2003
- Descendant · 3 generations on · 15 of its ownK090960 Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142…Hollister, Inc. · 2009
- Descendant · 4 generations on · 14 of its ownK110862 Vapro Plus Intermittent CatheterHollister Incorporated · 2011
- Descendant · 4 generations on · 13 of its ownK141642 Vapro Intermittent CatheterHollister Incorporated · 2014
Showing 5 of 57 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 57 · See all- K973070Conveen Easicath SetColoplast Corp. · 1997 · cites it directly55descendants
- K023254SpeedicathColoplast Corp. · 2003 · 2 generations on53descendants
- K090960Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064, 72084…Hollister, Inc. · 2009 · 3 generations on15descendants
- K110862Vapro Plus Intermittent CatheterHollister Incorporated · 2011 · 4 generations on14descendants
- K141642Vapro Intermittent CatheterHollister Incorporated · 2014 · 4 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K910022 | MMG/O'neil Urinary Catheterization System Kit | Medical Marketing Group | 1991 | — |
| +1 | K973070 | Conveen Easicath Set | Coloplast Corp. | 1997 | — |
| +2 | K023254 | Speedicath | Coloplast Corp. | 2003 | — |
| +3 | K090960 | Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064… | Hollister, Inc. | 2009 | — |
| +4 | K110862 | Vapro Plus Intermittent Catheter | Hollister Incorporated | 2011 | — |
| +4 | K141642 | Vapro Intermittent Catheter | Hollister Incorporated | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2003 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2019 | 4 | 0 |
| 2020 | 4 | 0 |
| 2022 | 7 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 4 | 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? (57)
See all 572 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K973070 (Coloplast Corp., 1997) has gone furthest, with 55 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/K910022 · printed Nov 5, 2026
Cite this page
510(k) Report. “K910022: MMG/O'neil Urinary Catheterization System Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K910022
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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