510(k) · Cleared
ClearedBever Unocated / Coated, Paediatric / Male / Female Nelaton-Tip / Tiemann-Tip Intermittent Catheter,
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hangzhou Bever Medical Devices Co., Ltd. · GBM Catheter, Urethral
Cleared on Feb 13, 2012 as substantially equivalent to K033023 (Rusch Intl., 2003) and 1 other predicate after a 270-day review. Its family tree reaches back 2 generations to 1990. 2 later devices descend from it.
- Decided
- Feb 13, 2012
- Review
- 270 days
- Class
- Class II
- Product code
- GBM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K896729 (1990). 6 ancestors in all, the oldest K896750 (1990). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK896729 Nelaton-, Female - or Tiemann CatheterUnoplast A/S · 1990 · Recalled
- 1 generation backK033023 Intermittent Urethral CathetersRusch Intl. · 2003
- This deviceK111405 Bever Unocated / Coated, Paediatric / Male / Female Nelaton-Tip /…Hangzhou Bever Medical Devices Co., Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK161445 PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC…Adapta Medical, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK142767 ThinkMed Intermittent Catheter with/without Hydrophilic CoatingThinkmed Medical Technology Co., Ltd. · 2015
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 |
|---|---|---|---|---|---|
| −2 | K896729 | Nelaton-, Female - or Tiemann Catheter | Unoplast A/S | 1990 | 14 |
| −1 | K033023 | Intermittent Urethral Catheters | Rusch Intl. | 2003 | — |
| 0 (this device) | K111405 | Bever Unocated / Coated, Paediatric / Male / Female Nelaton-Tip / Tiemann-Tip… | Hangzhou Bever Medical Devices Co., Ltd. | 2012 | — |
| +1 | K161445 | PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C | Adapta Medical, Inc. | 2016 | — |
| +1 | K142767 | ThinkMed Intermittent Catheter with/without Hydrophilic Coating | Thinkmed Medical Technology Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 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 GBM? 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 GBM device
- #1 K241734 Wellead® Hydrophilic Intermittent Catheter…score 10.2 · 5 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 |
|---|---|---|---|
| * | K033023 | Intermittent Urethral CathetersSummary page 1…R 876.5130, Product Code GBM) 4. Predicate Device: BEVER is claiming substantial equivalence to the following medical devices: Rflsch Intermittent Urethral Catheters - K033023 Astra Tech AB LoFrice PrimoT Single Use Urinary Catheter - K050874 5. Device Description BEVERTM Intermittent Catheter is sterile… | 2003 |
| * | K050874 | Astra Tech AB Lofric Primo Single Use Urinary CatheterSummary page 1…ing substantial equivalence to the following medical devices: Rflsch Intermittent Urethral Catheters - K033023 Astra Tech AB LoFrice PrimoT Single Use Urinary Catheter - K050874 5. Device Description BEVERTM Intermittent Catheter is sterile, single use device to be designed as an intermittent pathway for d… | 2005 |
What descends from it? (2)
2 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?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 13.1 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K161445 (Adapta Medical, Inc., 2016) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K033023.
How does its category compare?
All GBM devicesGBM Catheter, Urethral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · GBM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GBM
230in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GBM
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GBM
311in 2025
MAUDE reports naming product code GBM, 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 | 2 | — | 0 | 5 |
| 2008 | 0 | — | 5 | 18 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 33 |
| 2011 | 2 | — | 1 | 46 |
| 2012 | 3 | 139 | 0 | 32 |
| 2013 | 0 | — | 0 | 41 |
| 2014 | 1 | — | 0 | 19 |
| 2015 | 5 | 76 | 0 | 21 |
| 2016 | 3 | 112 | 0 | 49 |
| 2017 | 2 | — | 0 | 59 |
| 2018 | 6 | 93 | 0 | 82 |
| 2019 | 7 | 121 | 0 | 148 |
| 2020 | 6 | 230 | 0 | 144 |
| 2021 | 0 | — | 0 | 102 |
| 2022 | 2 | — | 0 | 283 |
| 2023 | 0 | — | 1 (1) | 202 |
| 2024 | 0 | — | 0 | 468 |
| 2025 | 1 | — | 1 | 311 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The BEVERm intermittent catheter is indicated for intermittent catheterization of the urethra for those individuals who are unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode. The catheter is inserted into urethra to reach the bladder allowing urine to drain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111405 · printed Nov 4, 2026
Cite this page
510(k) Report. “K111405: Bever Unocated / Coated, Paediatric / Male / Female Nelaton-Tip / Tiemann-Tip Intermittent Catheter,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K111405
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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