510(k) · Cleared
ClearedBard Ritecath Intermittent 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 Apr 4, 2014 as substantially equivalent to K100878 (Coloplast Manufacturing Us, LLC, 2010) after a 143-day review. Its family tree reaches back 2 generations to 2001. 3 later devices descend from it.
- Decided
- Apr 4, 2014
- Review
- 143 days
- Class
- Class II
- Product code
- EZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003784 (2001). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK003784 Mentor Self-Cath PlusMentor Corp. · 2001
- 1 generation backK100878 Self Cath CatheterColoplast Manufacturing Us, LLC · 2010
- This deviceK133470 Bard Ritecath Intermittent CatheterC.R. Bard, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK142575 Bard RiteCath Intermittent Urinary CatheterC.R. Bard, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK212430 BONREE Nelaton CatheterBonree Medical Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK170233 Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary…Zhanjiang Star Enterprise Co., Ltd. · 2017
Most influential descendants
Showing 3 of 3 · See all- K142575Bard RiteCath Intermittent Urinary CatheterC.R. Bard, Inc. · 2014 · cites it directly2descendants
- K212430BONREE Nelaton CatheterBonree Medical Co., Ltd. · 2022 · 2 generations on0descendants
- K170233Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex…Zhanjiang Star Enterprise Co., Ltd. · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003784 | Mentor Self-Cath Plus | Mentor Corp. | 2001 | — |
| −1 | K100878 | Self Cath Catheter | Coloplast Manufacturing Us, LLC | 2010 | — |
| 0 (this device) | K133470 | Bard Ritecath Intermittent Catheter | C.R. Bard, Inc. | 2014 | — |
| +1 | K142575 | Bard RiteCath Intermittent Urinary Catheter | C.R. Bard, Inc. | 2014 | — |
| +2 | K212430 | BONREE Nelaton Catheter | Bonree Medical Co., Ltd. | 2022 | — |
| +2 | K170233 | Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter… | Zhanjiang Star Enterprise Co., Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K100878 | Self Cath CatheterSummary page 1…ZD Secondary Product Codes: EZC Legally marketed device to which substantial equivalence is claimed: . Coloplast A/s Self Cath Catheter, K100878 Device Description The Bard RiteCath Intermittent Urinary Catheter is a biocompatible, polyvinyl chloride (PVC) catheter used to… | 2010 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142575 | Bard RiteCath Intermittent Urinary Catheter | 2014 | 2 |
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 13 years and passes through 3 companies; a new generation was cleared every 9.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K142575 (C.R. Bard, Inc., 2014) has gone furthest, with 2 descendants of its own.
- 7 other devices also cite its predicate K100878.
How does its category compare?
All EZD devicesEZD Catheter, Straight: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Bard RiteCath Intermittent Urinary Catheter Is Intended for use by male and female patients for draining urine from the bladder.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133470 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133470: Bard Ritecath Intermittent Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133470
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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