510(k) · Cleared
ClearedVenotrain Curaflow
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bauerfeind AG · DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
Cleared on Oct 4, 2011 as substantially equivalent to K061411 (Torbut Group, Inc., 2006) and 1 other predicate after a 112-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Oct 4, 2011
- Review
- 112 days
- Class
- Class II
- Product code
- DWL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K963573 (1996). 7 ancestors in all, the oldest K925154 (1994). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K963573 | Elvarex | Jobst A Beiersdorf Co. | 1996 | — |
| −2 | K021102 | DM Sleeve | Emily Iker M.D., A.P.C. | 2002 | — |
| −1 | K061411 | Torbot Vascular Compression Garments | Torbut Group, Inc. | 2006 | — |
| 0 (this device) | K111662 | Venotrain Curaflow | Bauerfeind AG | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 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 DWL? 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? (2)
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 |
|---|---|---|---|
| * | K061411 | Torbot Vascular Compression GarmentsSummary page 1…eneral Hospital Predicate Devices Bauerfeind's VenoTrain curaflow is substantially equivalent, for the purpose of this 51 0(k), to Torbot Vascular Compression Garments (K06141 1) and Elvarex compression garments (K963573). Device Description The VenoTrain curaflow compression garments help to prevent pooli… | 2006 |
| * | K963573 | ElvarexSummary page 1…d's VenoTrain curaflow is substantially equivalent, for the purpose of this 51 0(k), to Torbot Vascular Compression Garments (K06141 1) and Elvarex compression garments (K963573). Device Description The VenoTrain curaflow compression garments help to prevent pooling of blood and fluid in the extremities by… | 1996 |
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 15 years and passes through 4 companies; a new generation was cleared every 5.0 years on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All DWL devicesDWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DWL
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · DWL
111in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DWL
No recall names DWL since 2007.
Adverse event reports per year · DWL
2in 2025
MAUDE reports naming product code DWL, 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 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 3 |
| 2010 | 3 | 214 | 0 | 7 |
| 2011 | 2 | — | 0 | 4 |
| 2012 | 5 | 43 | 0 | 10 |
| 2013 | 3 | 111 | 0 | 4 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The VenoTrain curaflow compression garments are intended to be used to apply pressure to the extremities and are indicated for use in management of lymphedema and other edematous conditions, phlebitis, and vascular disorders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111662 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111662: Venotrain Curaflow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111662
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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