510(k) · Cleared
Recalled · Class II · 2017Hydrosil; Magic; Personal Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rochester Medical Corp. · EZD Catheter, Straight
Cleared on May 14, 2013 as substantially equivalent to K000723 (Rochester Medical Corp., 2000) and 1 other predicate after a 245-day review. Its family tree reaches back 4 generations to 1991. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- May 14, 2013
- Review
- 245 days
- Class
- Class II
- Product code
- EZD
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 4 generations to K910022 (1991). 7 ancestors in all, the oldest K896750 (1990). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK910022 MMG/O'neil Urinary Catheterization System KitMedical Marketing Group · 1991
- 3 generations backK973070 Conveen Easicath SetColoplast Corp. · 1997
- 2 generations backK023254 SpeedicathColoplast Corp. · 2003
- 1 generation backK072808 Speedicath CompactColoplast Corp. · 2007
- This deviceK122785 Hydrosil; Magic; Personal CatheterRochester Medical Corp. · 2013
- Descendant · cites it directly · 1 of its ownK150345 Magic3 Go Intermittent Urinary CatheterC.R. Bard, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 0 of its ownK172247 Magic3 Go Intermittent Urinary CatheterC.R. Bard, Inc. · 2017 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K910022 | MMG/O'neil Urinary Catheterization System Kit | Medical Marketing Group | 1991 | — |
| −3 | K973070 | Conveen Easicath Set | Coloplast Corp. | 1997 | — |
| −2 | K023254 | Speedicath | Coloplast Corp. | 2003 | — |
| −1 | K072808 | Speedicath Compact | Coloplast Corp. | 2007 | — |
| 0 (this device) | K122785 | Hydrosil; Magic; Personal Catheter | Rochester Medical Corp. | 2013 | — |
| +1 | K150345 | Magic3 Go Intermittent Urinary Catheter | C.R. Bard, Inc. | 2015 | 2 |
| +2 | 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 |
|---|---|---|
| 2015 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K000723 | Hydrophilic Silicone Foley Catheter and Personal Catheter (Hydrophilic and…Summary page 1…Urological catheter and accessories (21 CFR 876.5130, Product Code EZD) Predicate Device(s): K000723 Rochester Medical Corporation Personal" Catheter (Hydrophilic)… | 2000 |
| * | K072808 | Speedicath CompactSummary page 1…K000723 Rochester Medical Corporation Personal" Catheter (Hydrophilic) K072808 Coloplast Corp. SpeediCath Compact Device Description: The H-ydrophilic Intermittent Uri… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150345 | Magic3 Go Intermittent Urinary Catheter | 2015 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 14, 2017 | Class II | Z-1307-2018 | Process control | Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed. |
| Sep 14, 2017 | Class II | Z-1308-2018 | Process control | Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed. |
| Sep 14, 2017 | Class II | Z-1309-2018 | Process control | Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K150345 (C.R. Bard, Inc., 2015) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K000723.
How does its category compare?
All EZD devicesEZD Catheter, Straight: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
For urological use only. Intended for use by patients for bladder management including urine drainage, collection and measurement. The devices are passed to the urinary bladder via the urethra.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122785 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122785: Hydrosil; Magic; Personal Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122785
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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