510(k) · Cleared
Recalled · Class II · 2025Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic 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 Nov 27, 2019 as substantially equivalent to K023254 (Coloplast Corp., 2003) after a 79-day review. Its family tree reaches back 3 generations to 1991. 1 later device descends from it. It has been recalled once.
- Decided
- Nov 27, 2019
- Review
- 79 days
- Class
- Class II
- Product code
- GBM
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K910022 (1991). 5 ancestors in all, the oldest K896750 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK910022 MMG/O'neil Urinary Catheterization System KitMedical Marketing Group · 1991
- 2 generations backK973070 Conveen Easicath SetColoplast Corp. · 1997
- 1 generation backK023254 SpeedicathColoplast Corp. · 2003
- This deviceK192468 Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal…Hangzhou Bever Medical Devices Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK251178 Ready to use Nelaton CatheterJamjoom Fullcare Corporation · 2026
Most influential descendants
Showing 1 of 1 · See all- K251178Ready to use Nelaton CatheterJamjoom Fullcare Corporation · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K910022 | MMG/O'neil Urinary Catheterization System Kit | Medical Marketing Group | 1991 | — |
| −2 | K973070 | Conveen Easicath Set | Coloplast Corp. | 1997 | — |
| −1 | K023254 | Speedicath | Coloplast Corp. | 2003 | — |
| 0 (this device) | K192468 | Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip… | Hangzhou Bever Medical Devices Co., Ltd. | 2019 | — |
| +1 | K251178 | Ready to use Nelaton Catheter | Jamjoom Fullcare Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (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 |
|---|---|---|---|
| * | K023254 | SpeedicathSummary page 4…ion Name: Urological catheter and accessories (21 CFR 876.5130) Product Code: GBM Regulation Class: II 4. Legally Marketed predicate(s): Predicate Device: SpeediCath - K023254 Reference Device(s): LoFric® PrimoTM - K122078 Self Cath - K100878 5. Device Description The Ready-to-Use Hydrophilic Catheter… | 2003 |
| † | K122078 | Lofric Primo, Lofric Hydro-Kit | 2012 |
| † | K100878 | Self Cath Catheter | 2010 |
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 |
|---|---|---|---|
| K251178 | Ready to use Nelaton Catheter | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 29, 2025 | Class II | Z-1061-2026 | Labeling Change Control | Labeling error, Incorrect expiration date |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 6.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K251178 (Jamjoom Fullcare Corporation, 2026) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K023254.
How does its category compare?
All GBM devicesGBM Catheter, Urethral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Ready-to-use Hydrophilic 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/K192468 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192468: Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192468
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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