510(k) · Cleared
ClearedConveen Easicath Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast Corp. · EZD Catheter, Straight
Cleared on Nov 6, 1997 as substantially equivalent to K910022 (Medical Marketing Group, 1991) after an 80-day review. Its family tree reaches back 1 generation to 1991. 55 later devices descend from it.
- Decided
- Nov 6, 1997
- Review
- 80 days
- Class
- Class II
- Product code
- EZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K910022 (1991). 55 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK910022 MMG/O'neil Urinary Catheterization System KitMedical Marketing Group · 1991
- This deviceK973070 Conveen Easicath SetColoplast Corp. · 1997
- Descendant · cites it directly · 53 of its ownK023254 SpeedicathColoplast Corp. · 2003
- Descendant · 2 generations on · 15 of its ownK090960 Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142…Hollister, Inc. · 2009
- Descendant · 3 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 · 2 generations on · 12 of its ownK072808 Speedicath CompactColoplast Corp. · 2007
Showing 5 of 55 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 55 · See all- K023254SpeedicathColoplast Corp. · 2003 · cites it directly53descendants
- K090960Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064, 72084…Hollister, Inc. · 2009 · 2 generations on15descendants
- K110862Vapro Plus Intermittent CatheterHollister Incorporated · 2011 · 3 generations on14descendants
- K141642Vapro Intermittent CatheterHollister Incorporated · 2014 · 3 generations on13descendants
- K072808Speedicath CompactColoplast Corp. · 2007 · 2 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910022 | MMG/O'neil Urinary Catheterization System Kit | Medical Marketing Group | 1991 | — |
| 0 (this device) | K973070 | Conveen Easicath Set | Coloplast Corp. | 1997 | — |
| +1 | K023254 | Speedicath | Coloplast Corp. | 2003 | — |
| +2 | K090960 | Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064… | Hollister, Inc. | 2009 | — |
| +3 | K110862 | Vapro Plus Intermittent Catheter | Hollister Incorporated | 2011 | — |
| +3 | K141642 | Vapro Intermittent Catheter | Hollister Incorporated | 2014 | — |
| +2 | K072808 | Speedicath Compact | Coloplast Corp. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 EZD? 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 EZD device
- #1 K241210 Luja Coudescore 16.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K910022 | MMG/O'neil Urinary Catheterization System KitSummary page 1…ubstantial Equivalence The Conveen® EasiCath Set is substantially equivalent to the O'Neil Urinary Catheterization System™ manufactured by Medical Marketing Group, Inc. K910022. . Intended Use The Conveen® EasiCath Set is indicated for use by patients for intermittent catheterization for the purpose of… | 1991 |
| † | K896729 | Nelaton-, Female - or Tiemann Catheter | 1990 |
What descends from it? (55)
See all 553 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?
How does its category compare?
All EZD devicesEZD Catheter, Straight: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EZD
11so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · EZD
130in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EZD
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EZD
288in 2025
MAUDE reports naming product code EZD, 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 | 4 | 121 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 4 |
| 2010 | 2 | — | 0 | 6 |
| 2011 | 4 | 116 | 1 | 4 |
| 2012 | 2 | — | 1 | 2 |
| 2013 | 4 | 110 | 0 | 18 |
| 2014 | 5 | 91 | 1 | 17 |
| 2015 | 1 | — | 0 | 21 |
| 2016 | 3 | 83 | 0 | 21 |
| 2017 | 2 | — | 0 | 120 |
| 2018 | 3 | 122 | 0 | 390 |
| 2019 | 0 | — | 0 | 466 |
| 2020 | 1 | — | 0 | 563 |
| 2021 | 0 | — | 0 | 994 |
| 2022 | 10 | 288 | 0 | 487 |
| 2023 | 6 | 214 | 0 | 553 |
| 2024 | 5 | 147 | 0 | 116 |
| 2025 | 6 | 130 | 0 | 288 |
| 2026 | 11 | 146 | 0 | — |
What is it indicated for?
The Conveen® EasiCath Set is indicated for use by patients for
intermittent catheterization for the purpose of bladder drainage.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973070 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973070: Conveen Easicath Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973070
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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