510(k) · Cleared
ClearedRX Fit Medical Stockings
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elastic Therapy, Inc. · DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
Cleared on Dec 6, 1993 after a 392-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Dec 6, 1993
- Review
- 392 days
- Class
- Class II
- Product code
- DWL
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK925643 RX Fit Medical StockingsElastic Therapy, Inc. · 1993
- Descendant · cites it directly · 1 of its ownK090921 Anti-Embolism Stockings, Models 71055-00000-02, 71057-00000-02…Beiersdorf, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK123398 DR. Scholl's Compression SocksRenfro Corporation · 2012
- Descendant · 2 generations on · 0 of its ownK101224 Saphenamedical Anti-Embolism StockingsGriffiths and Nielsen, Ltd. · 2010
Most influential descendants
Showing 3 of 3 · See all- K090921Anti-Embolism Stockings, Models 71055-00000-02, 71057-00000-02, 71059-00000-02…Beiersdorf, Inc. · 2009 · cites it directly1descendant
- K123398DR. Scholl's Compression SocksRenfro Corporation · 2012 · cites it directly0descendants
- K101224Saphenamedical Anti-Embolism StockingsGriffiths and Nielsen, Ltd. · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K925643 | RX Fit Medical Stockings | Elastic Therapy, Inc. | 1993 | — |
| +1 | K090921 | Anti-Embolism Stockings, Models 71055-00000-02, 71057-00000-02… | Beiersdorf, Inc. | 2009 | — |
| +1 | K123398 | DR. Scholl's Compression Socks | Renfro Corporation | 2012 | — |
| +2 | K101224 | Saphenamedical Anti-Embolism Stockings | Griffiths and Nielsen, Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
2 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, K090921 (Beiersdorf, Inc., 2009) has gone furthest, with 1 descendant 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 | — |
https://510kreport.com/device/K925643 · printed Nov 6, 2026
Cite this page
510(k) Report. “K925643: RX Fit Medical Stockings.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K925643
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026