510(k) · Cleared
ClearedBossong Hosiery Medical Compression Stockings 8-15 MMHG, Bossong Hosiery Anti-Embolism Stockings 10-20 MMHG, Bossong Hos
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bossong Hosiery Mills, Inc. · DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
Cleared on Apr 2, 2013 after a 111-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Apr 2, 2013
- Review
- 111 days
- Class
- Class II
- Product code
- DWL
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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. 2013, 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?
8-15 mmHI! Mild * For tired, aching legs, minor leg swelling, leg pain, poor blood circulation 10-20 mmHg Anti-Embolism Stocking *Helps prevent edema and leg discomfort, and helps prevent deep vein thrombosis (DVT) in patients subjected to immobility. 15-20 mmHg Moderate * For mild varicose veins, post surgery, poor blood circulation, leg discomfort, mild to moderate swelling, tired and aching legs " Helps prevent deep vein thrombosis for long distance…
Read the full statement (140 words)
8-15 mmHI! Mild
* For tired, aching legs, minor leg swelling, leg pain, poor blood circulation
10-20 mmHg Anti-Embolism Stocking
*Helps prevent edema and leg discomfort, and helps prevent deep vein thrombosis (DVT) in patients subjected to immobility.
15-20 mmHg Moderate
* For mild varicose veins, post surgery, poor blood circulation, leg discomfort, mild to moderate swelling, tired and aching legs
" Helps prevent deep vein thrombosis for long distance travelers and edema
20-30 mmHg Firm
" For varicose veins, post surgery, venous insufficiency, moderate to severe varicosis, moderate swelling
"Helps prevent deep vein thmombosis for long distance travelers and edema
30-40 inmHe Extra Firm
" For edema, after healing of leg ulcers, severe chronic venous insufficiency, postphlebitic syndrome, post deep vein thrombosis (DVT), advanced varicose veins, phlebitis and reversible lymphedern
* Post varicose vein surgery, vein stripping, scierotherapy, plebectomy
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K123820 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123820: Bossong Hosiery Medical Compression Stockings 8-15 MMHG, Bossong Hosiery Anti-Embolism Stockings 10-20 MMHG, Bossong Hos.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123820
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026