510(k) · Cleared
ClearedFULL CARE Disposable PVC Nelaton Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shaoxing Fuqing Health Products Co., Ltd. · EZD Catheter, Straight
Cleared on Mar 3, 2016 as substantially equivalent to K072539 (Cure Medical, LLC, 2007) and 3 other predicates after a 248-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- Mar 3, 2016
- Review
- 248 days
- Class
- Class II
- Product code
- EZD
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K896729 (1990). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK896729 Nelaton-, Female - or Tiemann CatheterUnoplast A/S · 1990 · Recalled
- 4 generations backK033023 Intermittent Urethral CathetersRusch Intl. · 2003
- 3 generations backK072539 Cure CatheterCure Medical, LLC · 2007 · Recalled
- 2 generations backK110653 Cure CatheterCure Medical, LLC · 2011 · Recalled
- 1 generation backK132500 Cure Catheter Female, Cure Catheter Male, Cure Catheter Coude, Cure…Cure Medical, LLC · 2013
- This deviceK151745 FULL CARE Disposable PVC Nelaton CatheterShaoxing Fuqing Health Products Co., Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K896729 | Nelaton-, Female - or Tiemann Catheter | Unoplast A/S | 1990 | 14 |
| −4 | K033023 | Intermittent Urethral Catheters | Rusch Intl. | 2003 | — |
| −3 | K072539 | Cure Catheter | Cure Medical, LLC | 2007 | 1 |
| −2 | K110653 | Cure Catheter | Cure Medical, LLC | 2011 | 1 |
| −1 | K132500 | Cure Catheter Female, Cure Catheter Male, Cure Catheter Coude, Cure Catheter… | Cure Medical, LLC | 2013 | — |
| 0 (this device) | K151745 | FULL CARE Disposable PVC Nelaton Catheter | Shaoxing Fuqing Health Products Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 2 | 0 |
| 2008 | 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? (4)
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 |
|---|---|---|---|
| * | K072539 | Cure CatheterSummary page 6…1/8 III. PREDICATE DEVICE Cure CatheterTM, K072539 Cure Pediatric Catheter, K110653… | 2007 |
| * | K110653 | Cure CatheterSummary page 6…PREDICATE DEVICE Cure CatheterTM, K072539 Cure Pediatric Catheter, K110653 Cure CatheterTM Hydrophilic Coated, K132500… | 2011 |
| * | K132500 | Cure Catheter Female, Cure Catheter Male, Cure Catheter Coude, Cure Catheter Pediatric…Summary page 6…Cure Pediatric Catheter, K110653 Cure CatheterTM Hydrophilic Coated, K132500 Cure CatheterTM Closed System, K080881… | 2013 |
| * | K080881 | Cure Catheter Closed SystemSummary page 6…Cure CatheterTM Hydrophilic Coated, K132500 Cure CatheterTM Closed System, K080881 These predicates have not been subject to a… | 2008 |
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 26 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 4 of the 9 ancestors have a recall of any class.
- 2 other devices also cite its predicate K072539.
How does its category compare?
All EZD devicesEZD Catheter, Straight: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 FULL CARE Disposable PVC Nelaton 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. The urinary catheter comes in a variety of sizes packaged sterile for single-use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151745 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151745: FULL CARE Disposable PVC 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/K151745
Report an extraction error
Are you the manufacturer?
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