510(k) · Cleared
ClearedElvarex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jobst A Beiersdorf Co. · DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
Cleared on Oct 16, 1996 after a 41-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Oct 16, 1996
- Review
- 41 days
- Class
- Class II
- Product code
- DWL
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 4 citing it directly.
- This deviceK963573 ElvarexJobst A Beiersdorf Co. · 1996
- Descendant · cites it directly · 2 of its ownK021102 DM SleeveEmily Iker M.D., A.P.C. · 2002
- Descendant · cites it directly · 1 of its ownK061411 Torbot Vascular Compression GarmentsTorbut Group, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK111662 Venotrain CuraflowBauerfeind AG · 2011
- Descendant · cites it directly · 0 of its ownK022233 HydrobootIncappe, Inc. · 2002
Most influential descendants
Showing 4 of 4 · See all- K021102DM SleeveEmily Iker M.D., A.P.C. · 2002 · cites it directly2descendants
- K061411Torbot Vascular Compression GarmentsTorbut Group, Inc. · 2006 · cites it directly1descendant
- K111662Venotrain CuraflowBauerfeind AG · 2011 · cites it directly0descendants
- K022233HydrobootIncappe, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963573 | Elvarex | Jobst A Beiersdorf Co. | 1996 | — |
| +1 | K021102 | DM Sleeve | Emily Iker M.D., A.P.C. | 2002 | — |
| +1 | K061411 | Torbot Vascular Compression Garments | Torbut Group, Inc. | 2006 | — |
| +1 | K111662 | Venotrain Curaflow | Bauerfeind AG | 2011 | — |
| +1 | K022233 | Hydroboot | Incappe, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2006 | 1 | 0 |
| 2011 | 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? (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 |
|---|---|---|---|
| * | — | Jobst-Custom garments Named without a submission number |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K021102 (Emily Iker M.D., A.P.C., 2002) has gone furthest, with 2 descendants of its own.
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.
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?
Consequently, they can be used to treat the same indications, i.e. CVl, edema, lymphedema, phlebitis and vascular malformations.
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/K963573 · printed Nov 5, 2026
Cite this page
510(k) Report. “K963573: Elvarex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963573
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