510(k) · Cleared
ClearedPhasTIPP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
LeMaitre Vascular, Inc. · DWQ Stripper, Vein, External
Cleared on Mar 31, 2022 as substantially equivalent to K032387 (Smith & Nephew, Inc., 2003) after a 202-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Mar 31, 2022
- Review
- 202 days
- Class
- Class II
- Product code
- DWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K964561 (1997). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK964561 Endolumina II Transillumination System 56FR E-5630, 50FR E-5030 and…Bioenterics Corp. · 1997
- 2 generations backK991323 Smith & Nephew Subcutaneous IlluminatorSmith & Nephew, Inc. · 1999
- 1 generation backK032387 Trivex SystemSmith & Nephew, Inc. · 2003 · Recalled
- This deviceK212894 PhasTIPPLeMaitre Vascular, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K964561 | Endolumina II Transillumination System 56FR E-5630, 50FR E-5030 and 40FR… | Bioenterics Corp. | 1997 | — |
| −2 | K991323 | Smith & Nephew Subcutaneous Illuminator | Smith & Nephew, Inc. | 1999 | — |
| −1 | K032387 | Trivex System | Smith & Nephew, Inc. | 2003 | 1 |
| 0 (this device) | 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 |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K032387 | Trivex SystemSummary page 5…e Resector for visualization of varicose veins and infusion of tumescent solution during an ambulatory phlebectomy procedure. Predicate Device: 510(k): K032387 Device Name: Trivex System SE Date: 10/29/2003 Regulation Number: 21CFR §870.4885 Device Class Name:… | 2003 |
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 3 companies; a new generation was cleared every 4.3 years on median.
- 4 of the 7 ancestors have a recall of any class.
How does its category compare?
All DWQ devicesDWQ Stripper, Vein, External: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
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?
The PhasTIPP System is indicated for use in ambulatory phlebectomy procedures for the resection and ablation of varicose veins. The Illuminator is also indicated for use without the Resector for visualization of varicose veins and infusion of tumescent solution during an ambulatory phlebectomy procedure.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212894 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212894: PhasTIPP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212894
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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