510(k) · Cleared
ClearedClearmedical/Novamedix Avi Foot Cover, Pair, Regular & Large Size
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clearmedical, Inc. · JOW Sleeve, Limb, Compressible
Cleared on Feb 6, 2002 after a 177-day review. The FDA summary names its predicate without a number.
- Decided
- Feb 6, 2002
- Review
- 177 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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? (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 |
|---|---|---|---|
| * | — | Novamedix Arterial Venous Impulse (AVI) Foot Covers distributed by Kendall Named without a submission number |
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.
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 A-V Impulse System foot pump is safe and effective for the following indications. The proper duration for use of each indication is subject to the clinical judgment of the prescribing physician. Recommended Guidelines are as follows: Indication Recommended Guidelines Circulation Enhancement For temporary impairments such as temporary trauma or disease conditions, continuous use until the condition is resolved. For chronic impairments, daily use…
Read the full statement (185 words)
The A-V Impulse System foot pump is safe and effective for the following indications. The proper duration for use of each indication is subject to the clinical judgment of the prescribing physician.
Recommended Guidelines are as follows:
Indication Recommended Guidelines
Circulation Enhancement For temporary impairments such as temporary trauma or disease conditions, continuous use until the condition is resolved. For chronic impairments, daily use depending on the severity of the patient’s condition and activity.
Deep Vein Thrombosis Prophylaxis Continuous use until the patient is fully ambulatory and weight bearing (not just mobilized)
Edema — Acute Continuous use until edema is reduced.
Indication Recommended Guidelines
Edema -- Chronic As required, but at least 4 hours per day.
Extremity Pain Incident to Trauma or Surgery Continuous use until severity of pain is reduced or physician recommends alternative therapy.
Leg Ulcers Continuous use until ulcer severity is reduced or physician recommends alternative therapy.
Venous Stasis/Venous Insufficiency For temporary impairments such as temporary trauma or disease conditions, continuous use until condition is resolved. For chronic impairments, daily use depending on the severity of the patient’s condition and activity level.
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/K012612 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012612: Clearmedical/Novamedix Avi Foot Cover, Pair, Regular & Large Size.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012612
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026