510(k) · Cleared
ClearedArtassist and Venassist
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aci Medical, LLC · JOW Sleeve, Limb, Compressible
Cleared on Feb 10, 2014 as substantially equivalent to K942530 (Aci Medical, Inc., 1996) after a 293-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.
- Decided
- Feb 10, 2014
- Review
- 293 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K942530 (1996). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K240499ARTAIRA Arterial Compression Device (AACD01)Airos Medical, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942530 | Art-Assist Model AA-1000 | Aci Medical, Inc. | 1996 | — |
| 0 (this device) | K131146 | Artassist and Venassist | Aci Medical, LLC | 2014 | — |
| +1 | K240499 | ARTAIRA Arterial Compression Device (AACD01) | Airos Medical, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (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 |
|---|---|---|---|
| * | K942530 | Art-Assist Model AA-1000Summary page 1…name - Compressible limb sleeve (21 CFR 870.5800, Product Code JOW) The legally marketed devices to which our firm is claiming equivalence is the ArtAssist device (K942530). Device description The ArtAssist device is a pneumatic compression device that applies pressures to the limbs in timed sequenc… | 1996 |
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 |
|---|---|---|---|
| K240499 | ARTAIRA Arterial Compression Device (AACD01) | 2024 | 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?
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
When surgery is contraindicated
While waiting for surgery
Intermittent claudication
Rest pain
Diabetic foot
schemic neuritis
Arterial ulcers
Gangrene
Poor runoff
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131146 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131146: Artassist and Venassist.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131146
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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