510(k) · Cleared
ClearedDR. Scholl's Compression Socks
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Renfro Corporation · DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
Cleared on Dec 18, 2012 as substantially equivalent to K925643 (Elastic Therapy, Inc., 1993) after a 43-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Dec 18, 2012
- Review
- 43 days
- Class
- Class II
- Product code
- DWL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K925643 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK925643 RX Fit Medical StockingsElastic Therapy, Inc. · 1993
- This deviceK123398 DR. Scholl's Compression SocksRenfro Corporation · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925643 | RX Fit Medical Stockings | Elastic Therapy, Inc. | 1993 | — |
| 0 (this device) | K123398 | DR. Scholl's Compression Socks | Renfro Corporation | 2012 | — |
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 |
|---|---|---|---|
| * | K925643 | RX Fit Medical StockingsSummary page 1…ICE Class 2, per 21 CFR 880.5780 CLASSIFICATION: PRODUCT CODE OWL PREDICATE DEVICES: Elastic Therapy, Inc. Rx Fit Medical Socks (K925643) Substantially Equivalent To: The Renfro Compression Socks are substantially equivalent in intended use, principal of operation… | 1993 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K925643.
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. 2012, 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 Renfro Compression Socks are intended to help prevent pooling of blood in the legs by controlled pressure in the legs and help prevent deep vein thrombosis (DVT), edema and leg discomfort in individuals subjected to immobility
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123398 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123398: DR. Scholl's Compression Socks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123398
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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