510(k) · Cleared
Recalled · 2004Trivex System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · DWQ Stripper, Vein, External
Cleared on Oct 29, 2003 as substantially equivalent to K990723 (Smith & Nephew, Inc., 1999) and 2 other predicates after an 86-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it. It has been recalled once.
- Decided
- Oct 29, 2003
- Review
- 86 days
- Class
- Class II
- Product code
- DWQ
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 2 generations to K964561 (1997). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK964561 Endolumina II Transillumination System 56FR E-5630, 50FR E-5030 and…Bioenterics Corp. · 1997
- 1 generation backK991323 Smith & Nephew Subcutaneous IlluminatorSmith & Nephew, Inc. · 1999
- This deviceK032387 Trivex SystemSmith & Nephew, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK212894 PhasTIPPLeMaitre Vascular, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K212894PhasTIPPLeMaitre Vascular, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K964561 | Endolumina II Transillumination System 56FR E-5630, 50FR E-5030 and 40FR… | Bioenterics Corp. | 1997 | — |
| −1 | K991323 | Smith & Nephew Subcutaneous Illuminator | Smith & Nephew, Inc. | 1999 | — |
| 0 (this device) | K032387 | Trivex System | Smith & Nephew, Inc. | 2003 | — |
| +1 | K212894 | PhasTIPP | LeMaitre Vascular, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 DWQ? 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 DWQ device
- #1 K212894 PhasTIPPscore 3.7 · 3 generations · no Class I recall
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K990723 | Dyonics Varicose Vein Ablation BladeSummary page 1…amental Scientific Technology to the following legally marketed device in commercial distribution: The DyonicsB Varicose Vein Ablation System - K990723, Subcutaneous Illuminator - K991323, Smith & Nephew Xenon Light Source - K994… | 1999 |
| * | K991323 | Smith & Nephew Subcutaneous IlluminatorSummary page 1…d device in commercial distribution: The DyonicsB Varicose Vein Ablation System - K990723, Subcutaneous Illuminator - K991323, Smith & Nephew Xenon Light Source - K994084, and H.K. Surgical Klein Pump - KO12044.… | 1999 |
| * | K994084 | Smith & Nephew Xenon Light Sources and AccessoriesSummary page 1…icsB Varicose Vein Ablation System - K990723, Subcutaneous Illuminator - K991323, Smith & Nephew Xenon Light Source - K994084, and H.K. Surgical Klein Pump - KO12044.… | 2000 |
| Kept off the family tree | K012044 | FDA’s K012044 is BI-Phasic Infiltrator Our reading of the summary gave K012044, FDA’s number for BI-Phasic Infiltrator (Reliance Medical Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “H.K. Surgical Klein Pump”. Kept off the family tree. | 2001 |
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 |
|---|---|---|---|
| K212894 | PhasTIPP | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 12, 2004 | Not classified | Z-1105-2007 | Other | Build-up of static charge in Pneumatic Footswitch tubing may cause control unit to reset to default settings in the operating room during surgery. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 4.3 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K212894 (LeMaitre Vascular, Inc., 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DWQ devicesDWQ Stripper, Vein, External: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DWQ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · DWQ
Too few DWQ 510(k)s in any year since 2007 to give a median.
Recalls per year · DWQ
No recall names DWQ since 2007.
Adverse event reports per year · DWQ
5in 2025
MAUDE reports naming product code DWQ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 36 |
| 2019 | 0 | — | 0 | 29 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Indicated for use in ambulatory phlebectomy procedures for resection and ablation of
varicose veins.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032387 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032387: Trivex System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032387
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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