510(k) · Cleared
Recalled · Class II · 2023Magic3 Go Intermittent Urinary Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · EZD Catheter, Straight
Cleared on May 11, 2015 as substantially equivalent to K122785 (Rochester Medical Corp., 2013) after an 89-day review. Its family tree reaches back 5 generations to 1991. 1 later device descends from it. It has been recalled 2 times.
- Decided
- May 11, 2015
- Review
- 89 days
- Class
- Class II
- Product code
- EZD
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 5 generations to K910022 (1991). 8 ancestors in all, the oldest K896750 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK910022 MMG/O'neil Urinary Catheterization System KitMedical Marketing Group · 1991
- 4 generations backK973070 Conveen Easicath SetColoplast Corp. · 1997
- 3 generations backK023254 SpeedicathColoplast Corp. · 2003
- 2 generations backK072808 Speedicath CompactColoplast Corp. · 2007
- 1 generation backK122785 Hydrosil; Magic; Personal CatheterRochester Medical Corp. · 2013 · Recalled
- This deviceK150345 Magic3 Go Intermittent Urinary CatheterC.R. Bard, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK172247 Magic3 Go Intermittent Urinary CatheterC.R. Bard, Inc. · 2017 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K172247Magic3 Go Intermittent Urinary CatheterC.R. Bard, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K910022 | MMG/O'neil Urinary Catheterization System Kit | Medical Marketing Group | 1991 | — |
| −4 | K973070 | Conveen Easicath Set | Coloplast Corp. | 1997 | — |
| −3 | K023254 | Speedicath | Coloplast Corp. | 2003 | — |
| −2 | K072808 | Speedicath Compact | Coloplast Corp. | 2007 | — |
| −1 | K122785 | Hydrosil; Magic; Personal Catheter | Rochester Medical Corp. | 2013 | 3 |
| 0 (this device) | K150345 | Magic3 Go Intermittent Urinary Catheter | C.R. Bard, Inc. | 2015 | — |
| +1 | K172247 | Magic3 Go Intermittent Urinary Catheter | C.R. Bard, Inc. | 2017 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 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 |
|---|---|---|---|
| * | K122785 | Hydrosil; Magic; Personal CatheterSummary page 4…Code: EZD Predicate Device: Legally marketed device to which substantial equivalence is claimed HydroSil, Magic, Personal Catheter – K122785 Device Description Magic3 Go™ Intermittent Urinary Catheter is a ready-to-use silicone intermittent urinary cathete… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172247 | Magic3 Go Intermittent Urinary Catheter | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 20, 2023 | Class II | Z-1701-2023 | Under Investigation by firm | Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility. |
| Apr 20, 2023 | Class II | Z-1698-2023 | Under Investigation by firm | Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K172247 (C.R. Bard, Inc., 2017) has gone furthest, with 0 descendants of its own.
How does its category compare?
All EZD devicesEZD Catheter, Straight: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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 Magic3 Go™ Intermittent Urinary Catheter is intended for urological use only. It is intended for use by adult female patients for bladder management including urine drainage, collection, and measurement. The device is passed to the urinary bladder via the urethra.
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/K150345 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150345: Magic3 Go Intermittent Urinary Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150345
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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