510(k) · Cleared
ClearedVapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184,
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hollister, Inc. · GBM Catheter, Urethral
Cleared on Aug 20, 2009 as substantially equivalent to K050874 (Astra Tech, Inc., 2005) and 2 other predicates after a 136-day review. Its family tree reaches back 3 generations to 1991. 15 later devices descend from it.
- Decided
- Aug 20, 2009
- Review
- 136 days
- Class
- Class II
- Product code
- GBM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K910022 (1991). 11 ancestors in all, the oldest K896750 (1990). 15 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK910022 MMG/O'neil Urinary Catheterization System KitMedical Marketing Group · 1991
- 2 generations backK973070 Conveen Easicath SetColoplast Corp. · 1997
- 1 generation backK023254 SpeedicathColoplast Corp. · 2003
- This deviceK090960 Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142…Hollister, Inc. · 2009
- Descendant · cites it directly · 14 of its ownK110862 Vapro Plus Intermittent CatheterHollister Incorporated · 2011
- Descendant · cites it directly · 13 of its ownK141642 Vapro Intermittent CatheterHollister Incorporated · 2014
- Descendant · 2 generations on · 6 of its ownK180824 VaPro 2 Intermittent CatheterHollister Incorporated · 2018
- Descendant · 3 generations on · 3 of its ownK220667 Sleeved ICHollister Incorporated · 2022
- Descendant · 2 generations on · 3 of its ownK163179 Onli Intermittent CatheterHollister Incorporated · 2017
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K110862Vapro Plus Intermittent CatheterHollister Incorporated · 2011 · cites it directly14descendants
- K141642Vapro Intermittent CatheterHollister Incorporated · 2014 · cites it directly13descendants
- K180824VaPro 2 Intermittent CatheterHollister Incorporated · 2018 · 2 generations on6descendants
- K220667Sleeved ICHollister Incorporated · 2022 · 3 generations on3descendants
- K163179Onli Intermittent CatheterHollister Incorporated · 2017 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K910022 | MMG/O'neil Urinary Catheterization System Kit | Medical Marketing Group | 1991 | — |
| −2 | K973070 | Conveen Easicath Set | Coloplast Corp. | 1997 | — |
| −1 | K023254 | Speedicath | Coloplast Corp. | 2003 | — |
| 0 (this device) | K090960 | Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064… | Hollister, Inc. | 2009 | — |
| +1 | K110862 | Vapro Plus Intermittent Catheter | Hollister Incorporated | 2011 | — |
| +1 | K141642 | Vapro Intermittent Catheter | Hollister Incorporated | 2014 | — |
| +2 | K180824 | VaPro 2 Intermittent Catheter | Hollister Incorporated | 2018 | — |
| +3 | K220667 | Sleeved IC | Hollister Incorporated | 2022 | — |
| +2 | K163179 | Onli Intermittent Catheter | Hollister Incorporated | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2022 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 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? (3)
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 |
|---|---|---|---|
| * | K050874 | Astra Tech AB Lofric Primo Single Use Urinary CatheterSummary page 1…to the following products: Product 510(k) Astra Tech AB Lofric® Primo™ K050874 Single Use Urinary Catheter SpeediCath Catheter K023254… | 2005 |
| * | K023254 | SpeedicathSummary page 1…Astra Tech AB Lofric® Primo™ K050874 Single Use Urinary Catheter SpeediCath Catheter K023254 Incare Advance/Advance Plus K013483 Intermittent Catheter Device De… | 2003 |
| * | K013483 | Incare Advance; Intermittent Catheter, Plus Intermittent Catheter, Plus KitSummary page 1…Single Use Urinary Catheter SpeediCath Catheter K023254 Incare Advance/Advance Plus K013483 Intermittent Catheter Device Description: The VaPro intermittent catheter is a hydrophilic coated… | 2002 |
What descends from it? (15)
See all 152 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?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 6.6 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K110862 (Hollister Incorporated, 2011) has gone furthest, with 14 descendants of its own.
- 5 other devices also cite its predicate K050874.
How does its category compare?
All GBM devicesGBM Catheter, Urethral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The VaPro intermittent catheter is a flexible tubular device that is inserted through the urethra by male, female and pediatric patients who need to drain urine from the bladder.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090960 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090960: Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090960
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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