510(k) · Cleared
ClearedA-V Impulse System Model 6060
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Powell,Goldstein,Frazer & Murphy · JOW Sleeve, Limb, Compressible
Cleared on Jul 28, 1997 after a 265-day review. The FDA summary names no predicate by number. 1 later device descends from it.
- Decided
- Jul 28, 1997
- Review
- 265 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK964425 A-V Impulse System Model 6060Powell,Goldstein,Frazer & Murphy · 1997
- Descendant · cites it directly · 0 of its ownK052691 Suretek Medical Reprocessed Compression SleevesSuretek Medical · 2006
Most influential descendants
Showing 1 of 1 · See all- K052691Suretek Medical Reprocessed Compression SleevesSuretek Medical · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964425 | A-V Impulse System Model 6060 | Powell,Goldstein,Frazer & Murphy | 1997 | — |
| +1 | K052691 | Suretek Medical Reprocessed Compression Sleeves | Suretek Medical | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 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?
The FDA summary names no predicate by number.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052691 | Suretek Medical Reprocessed Compression Sleeves | 2006 | 0 |
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, K052691 (Suretek Medical, 2006) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Lower Extremity Reduces acute edema, such as elevated compartment pressures, edema secondary to trauma and/or surgical procedures, post-bypass graft edema, post-operative edema secondary to venous ligation or venous stripping and edema secondary to sprains, strains and sports related injuries of the lower extremity. Reduces chronic edema. Assists in treating patients at risk for deep vein thrombosis (DVT) and Pulmonary embolism (PE), including providing…
Read the full statement (230 words)
Lower Extremity
Reduces acute edema, such as elevated compartment pressures, edema secondary to trauma and/or surgical procedures, post-bypass graft edema, post-operative edema secondary to venous ligation or venous stripping and edema secondary to sprains, strains and sports related injuries of the lower extremity.
Reduces chronic edema.
Assists in treating patients at risk for deep vein thrombosis (DVT) and Pulmonary embolism (PE), including providing pre-, intra, and post-operative prophylaxis for DVT and PE.
Relieves circulatory disorders secondary to diminished blood flow, such as ischemia secondary to peripheral vascular disease.
Assists healing of cutaneous ulcers.
Relieves pain, increases range of motion and limb mobility, and expedites return of function following trauma or surgery.
Treats venous stasis, venous insufficiency and varicose veins.
Reduces lymphedema, including lymphedema secondary to trauma and/or surgery and reduces or controls chronic lymphedema including post-paralytic lymphedema due to stroke or spinal cord injury.
Upper Extremity
Reduces acute edema, such as elevated compartment pressures, edema secondary to trauma and/or surgical procedures, and edema secondary to sprains, strains and other sports related injuries of the upper extremity.
Reduces chronic edema.
Reduces circulatory disorders secondary to diminished blood flow.
Relieves pain, increases range of motion and limb mobility, and expedites return of function following trauma or surgery.
Reduces lymphedema, including lymphedema secondary to trauma and/or surgery and reduces or controls chronic lymphedema, including post-paralytic lymphedema due to stroke or spinal cord injury.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964425 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964425: A-V Impulse System Model 6060.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964425
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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