510(k) · Cleared
ClearedSunpolar Healthline, Model 100; Compfresh, Model 200; Naturex , Model 300; and Ihealth, Model 400 Stockings
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
E.C.I. USA Corporation · DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
Cleared on Mar 20, 2007 as substantially equivalent to K032325 (Bsn-Jobst, Inc., 2003) after a 176-day review. Its family tree reaches back 2 generations to 1995. 2 later devices descend from it.
- Decided
- Mar 20, 2007
- Review
- 176 days
- Class
- Class II
- Product code
- DWL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K955138 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK955138 Anti-EM/GP StockingsJobst Institute, Inc. · 1995
- 1 generation backK032325 Jobst Travel SocksBsn-Jobst, Inc. · 2003
- This deviceK062873 Sunpolar Healthline, Model 100; Compfresh, Model 200; Naturex…E.C.I. USA Corporation · 2007
- Descendant · cites it directly · 1 of its ownK101906 Shape to Fit Compression WearTsung Hau Technology Co., Ltd. · 2010
- Descendant · 2 generations on · 0 of its ownK123085 Futuro (TM) Travel Knee-Highs; Futuro (TM) Travel Socks; Futuro (TM)…3M Company · 2012
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 |
|---|---|---|---|---|---|
| −2 | K955138 | Anti-EM/GP Stockings | Jobst Institute, Inc. | 1995 | — |
| −1 | K032325 | Jobst Travel Socks | Bsn-Jobst, Inc. | 2003 | — |
| 0 (this device) | K062873 | Sunpolar Healthline, Model 100; Compfresh, Model 200; Naturex , Model 300; and… | E.C.I. USA Corporation | 2007 | — |
| +1 | K101906 | Shape to Fit Compression Wear | Tsung Hau Technology Co., Ltd. | 2010 | — |
| +2 | K123085 | Futuro (TM) Travel Knee-Highs; Futuro (TM) Travel Socks; Futuro (TM) Travel… | 3M Company | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K032325 | Jobst Travel SocksSummary page 1…which fall under the device classification of medical support stockings (21 CFR 880.5780). The SunPolar Netex Medical Stockings are equivalent to the Jobst Travel Sock (K032325). Both products are produced on circular knit machines and are made of nylon and spandex yarns. They provide similar compression… | 2003 |
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 |
|---|---|---|---|
| K101906 | Shape to Fit Compression Wear | 2010 | 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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 7.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K101906 (Tsung Hau Technology Co., Ltd., 2010) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K032325.
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. 2007, 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?
Helps to prevent the pooling of blood in the legs and apply controlled pressure to the legs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062873 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062873: Sunpolar Healthline, Model 100; Compfresh, Model 200; Naturex , Model 300; and Ihealth, Model 400 Stockings.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062873
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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