510(k) · Cleared
ClearedUmed Reprocessed Aircast Venaflow Foot Cuff; Umed Reprocessed Kendall SCD Express Sleeve; Umed Reprocessed Aircast Elite Calf Cuff 3040 3050; Umed Reprocessed CTC VP 501 Calf Cuff; Umed Reprocessed CTC VP 520 Foot Cuff
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United Medical Resources, LLC · JOW Sleeve, Limb, Compressible
Cleared on Oct 4, 2024 after a 108-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Oct 4, 2024
- Review
- 108 days
- Class
- Class II
- Product code
- JOW
- 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 JOW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JOW device
- #1 K253555 Flexitouch® Plus Advanced Pneumatic…score 14.8 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · JOW
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JOW
168in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JOW
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JOW
24in 2025
MAUDE reports naming product code JOW, 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 | 6 | 66 | 0 | 12 |
| 2008 | 4 | 112 | 7 | 36 |
| 2009 | 3 | 84 | 0 | 45 |
| 2010 | 18 | 71 | 2 | 66 |
| 2011 | 11 | 104 | 3 | 50 |
| 2012 | 13 | 63 | 2 | 100 |
| 2013 | 17 | 94 | 0 | 169 |
| 2014 | 16 | 91 | 0 | 93 |
| 2015 | 10 | 160 | 0 | 137 |
| 2016 | 9 | 121 | 0 | 150 |
| 2017 | 9 | 116 | 1 | 149 |
| 2018 | 11 | 136 | 0 | 114 |
| 2019 | 11 | 88 | 1 | 102 |
| 2020 | 14 | 158 | 0 | 50 |
| 2021 | 16 | 132 | 0 | 34 |
| 2022 | 7 | 80 | 0 | 27 |
| 2023 | 6 | 160 | 0 | 57 |
| 2024 | 8 | 197 | 0 | 30 |
| 2025 | 7 | 168 | 0 | 24 |
| 2026 | 6 | 252 | 0 | — |
What is it indicated for?
The UMED REPROCESSED CTC VP 520 FOOT CUFF is used in the same manner as intended by the original device manufacturer (OEM) to increase venous blood flow in patients at risk of developing Deep Vein Thrombosis (DVT) and pulmonary embolism (PE). The device is a prescription device for the use in a clinical setting or in the home. The UMED REPROCESSED CTC VP 501 CALF CUFF is used in the same manner as intended by the original device manufacturer (OEM) to…
Read the full statement (282 words)
The UMED REPROCESSED CTC VP 520 FOOT CUFF is used in the same manner as intended by the original device manufacturer (OEM) to increase venous blood flow in patients at risk of developing Deep Vein Thrombosis (DVT) and pulmonary embolism (PE). The device is a prescription device for the use in a clinical setting or in the home.
The UMED REPROCESSED CTC VP 501 CALF CUFF is used in the same manner as intended by the original device manufacturer (OEM) to increase venous blood flow in patients at risk of developing Deep Vein Thrombosis (DVT) and pulmonary embolism (PE). The device is a prescription device for the use in a clinical setting or in the home.
The UMED REPROCESSED AIRCAST ELITE CALF CUFF 3040 I 3050 is used in the s11me manner邸intended by the original device m叩ufacturer (OEM) lo incre邸e venous blood flow in at-risk patients in order to prevent deep vein thrombosis(DVT) and. The device is a prescription device for the use in a clinical setting or in the home.
The UMED REPROCESSED KENDALL SCD EXPRESS SLEEVE is used in the same manner as intended by the original device manufacturer (OEM) to increase venous blood flow in patients at risk of developing Deep Vein Thrombosis (DVT) and pulmonary embolism (PE). The device is a prescription device for the use in a clinical setting or in the home.
The UMED REPROCESSED AffiCAST VENAFLOW FOOT CUFF is used in the same manner as intended by the original device manufacturer (OEM) to increase venous blood flow in at- risk patients in order to prevent deep vein thrombosis(DVD. The device is a prescription device for the use in a clinical setting or in the home.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K241746 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241746: Umed Reprocessed Aircast Venaflow Foot Cuff; Umed Reprocessed Kendall SCD Express Sleeve; Umed Reprocessed Aircast Elite Calf Cuff 3040 3050; Umed Reprocessed CTC VP 501 Calf Cuff; Umed Reprocessed CTC VP 520 Foot Cuff.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241746
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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