510(k) · Cleared
ClearedThinkMed Intermittent Catheter with/without Hydrophilic Coating
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thinkmed Medical Technology Co., Ltd. · GBM Catheter, Urethral
Cleared on Feb 3, 2015 as substantially equivalent to K111405 (Hangzhou Bever Medical Devices Co., Ltd., 2012) after a 131-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Feb 3, 2015
- Review
- 131 days
- Class
- Class II
- Product code
- GBM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K896729 (1990). 7 ancestors in all, the oldest K896750 (1990). No later device cites it as a predicate yet.
- Root · 3 generations backK896729 Nelaton-, Female - or Tiemann CatheterUnoplast A/S · 1990 · Recalled
- 2 generations backK033023 Intermittent Urethral CathetersRusch Intl. · 2003
- 1 generation backK111405 Bever Unocated / Coated, Paediatric / Male / Female Nelaton-Tip /…Hangzhou Bever Medical Devices Co., Ltd. · 2012
- This deviceK142767 ThinkMed Intermittent Catheter with/without Hydrophilic CoatingThinkmed Medical Technology Co., Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K896729 | Nelaton-, Female - or Tiemann Catheter | Unoplast A/S | 1990 | 14 |
| −2 | K033023 | Intermittent Urethral Catheters | Rusch Intl. | 2003 | — |
| −1 | K111405 | Bever Unocated / Coated, Paediatric / Male / Female Nelaton-Tip / Tiemann-Tip… | Hangzhou Bever Medical Devices Co., Ltd. | 2012 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K111405 | Bever Unocated / Coated, Paediatric / Male / Female Nelaton-Tip / Tiemann-Tip…Summary page 4…GBM Submission Type: 510(k) Regulation Number: 876.51306 3. Predicate Devices Information: Trade Name: BEVER Intermittent Catheter 510(K) Number: K111405 Submitter: Hangzhou Bever Medical Devices Co., Ltd 4. Devices Description: ThinkMed Intermittent Catheter is sterile, sing… | 2012 |
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 25 years and passes through 4 companies; a new generation was cleared every 8.1 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 1 other device also cites its predicate K111405.
How does its category compare?
All GBM devicesGBM Catheter, Urethral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 ThinkMed Intermittent Catheter with/without Hydrophilic Coating 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/K142767 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142767: ThinkMed Intermittent Catheter with/without Hydrophilic Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142767
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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