510(k) · Cleared
ClearedDM Sleeve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emily Iker M.D., A.P.C. · DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
Cleared on May 8, 2002 as substantially equivalent to K001300 (Confection Medicale D.R., Inc., 2000) and 2 other predicates after a 34-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it.
- Decided
- May 8, 2002
- Review
- 34 days
- Class
- Class II
- Product code
- DWL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K963573 (1996). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK963573 ElvarexJobst A Beiersdorf Co. · 1996
- This deviceK021102 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 · 2 generations on · 0 of its ownK111662 Venotrain CuraflowBauerfeind AG · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963573 | Elvarex | Jobst A Beiersdorf Co. | 1996 | — |
| 0 (this device) | K021102 | DM Sleeve | Emily Iker M.D., A.P.C. | 2002 | — |
| +1 | K061411 | Torbot Vascular Compression Garments | Torbut Group, Inc. | 2006 | — |
| +2 | K111662 | Venotrain Curaflow | Bauerfeind AG | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K001300 | D. R. Medical Controlled Pressure GarmentsSummary page 1…mile: (310) 829-2282 Common or Usual Name Compression Sleeve Classification Name Medical Support Stocking Predicate Devices D.R. Medical Controlled Pressure Garments (K001300), Jobst Elvarex Compression Garments (K963573), and Jobst Ready-To-Wear Arm Sleeves (K991570). Intended Use The… | 2000 |
| * | K963573 | ElvarexSummary page 1…ression Sleeve Classification Name Medical Support Stocking Predicate Devices D.R. Medical Controlled Pressure Garments (K001300), Jobst Elvarex Compression Garments (K963573), and Jobst Ready-To-Wear Arm Sleeves (K991570). Intended Use The DM Sleeve™ is intended to be used to apply pre… | 1996 |
| * | K991570 | Jobst Ready-to-Wear Arm SleevesSummary page 1…port Stocking Predicate Devices D.R. Medical Controlled Pressure Garments (K001300), Jobst Elvarex Compression Garments (K963573), and Jobst Ready-To-Wear Arm Sleeves (K991570). Intended Use The DM Sleeve™ is intended to be used to apply pressure to the extremities and is indicated for u… | 1999 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061411 | Torbot Vascular Compression Garments | 2006 | 1 |
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?
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?
The DM Sleeve™ is intended to be used to apply pressure to the extremities and is indicated for use in the management of:
Lymphedema and other edematous conditions, 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/K021102 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021102: DM Sleeve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021102
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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