510(k) · Cleared
ClearedBONREE Nelaton Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bonree Medical Co., Ltd. · EZD Catheter, Straight
Cleared on Apr 29, 2022 as substantially equivalent to K142575 (C.R. Bard, Inc., 2014) after a 268-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Apr 29, 2022
- Review
- 268 days
- Class
- Class II
- Product code
- EZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K003784 (2001). No later device cites it as a predicate yet.
- Root · 4 generations backK003784 Mentor Self-Cath PlusMentor Corp. · 2001
- 3 generations backK100878 Self Cath CatheterColoplast Manufacturing Us, LLC · 2010
- 2 generations backK133470 Bard Ritecath Intermittent CatheterC.R. Bard, Inc. · 2014
- 1 generation backK142575 Bard RiteCath Intermittent Urinary CatheterC.R. Bard, Inc. · 2014
- This deviceK212430 BONREE Nelaton CatheterBonree Medical Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003784 | Mentor Self-Cath Plus | Mentor Corp. | 2001 | — |
| −3 | K100878 | Self Cath Catheter | Coloplast Manufacturing Us, LLC | 2010 | — |
| −2 | K133470 | Bard Ritecath Intermittent Catheter | C.R. Bard, Inc. | 2014 | — |
| −1 | K142575 | Bard RiteCath Intermittent Urinary Catheter | C.R. Bard, Inc. | 2014 | — |
| 0 (this device) | K212430 | BONREE Nelaton Catheter | Bonree Medical Co., Ltd. | 2022 | — |
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 |
|---|---|---|---|
| * | K142575 | Bard RiteCath Intermittent Urinary CatheterSummary page 4…Gastroenterology/Urology Product Code: EZD, EZC Regulatory Class: Class Ⅱ Predicate Device(s): K142575 – Bard RiteCath Intermittent Urinary Catheter 1. Indications for Use The BONREE Nelaton Catheter is used for clean intermittent… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 4 companies; a new generation was cleared every 7.5 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K142575.
How does its category compare?
All EZD devicesEZD Catheter, Straight: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 BONREE Nelaton Catheter is used for clean intermittent catheterization (CIC) treatment. It is intended for use by male, female and pediatric patients (2 years old to less than 12 years old) for draining urine from the bladder.
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/K212430 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212430: BONREE Nelaton Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212430
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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