510(k) · Cleared
ClearedAeroDVx System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sun Scientific, Inc. · JOW Sleeve, Limb, Compressible
Cleared on Jul 19, 2019 as substantially equivalent to K180389 (Suzhou Minhua Medical Apparatus Supplies Co., Ltd., 2018) after a 228-day review. Its family tree reaches back 7 generations to 1992.
- Decided
- Jul 19, 2019
- Review
- 228 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K915638 (1992). 18 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK915638 Talley TM200 Intermttent Compression UnitProgressive Medical Technology, Inc. · 1992
- 6 generations backK022340 Travelair Portable Compression SystemDynamic Air, Inc. · 2003
- 5 generations backK061125 Dvtcare CA5Doctors Orders · 2006
- 4 generations backK103187 Tripleplay-VT Vascular Therapy SystemWildcat Medical, Inc. · 2011
- 3 generations backK133274 Vena ProInnovamed Health, LLC · 2014
- 2 generations backK151189 Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention SystemDevon Medical Products · 2015
- 1 generation backK180389 Venera 508 Deep Vein Thrombosis (DVT) Prevention SystemSuzhou Minhua Medical Apparatus Supplies Co., Ltd. · 2018
- This deviceK183349 AeroDVx SystemSun Scientific, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K915638 | Talley TM200 Intermttent Compression Unit | Progressive Medical Technology, Inc. | 1992 | — |
| −6 | K022340 | Travelair Portable Compression System | Dynamic Air, Inc. | 2003 | — |
| −5 | K061125 | Dvtcare CA5 | Doctors Orders | 2006 | — |
| −4 | K103187 | Tripleplay-VT Vascular Therapy System | Wildcat Medical, Inc. | 2011 | — |
| −3 | K133274 | Vena Pro | Innovamed Health, LLC | 2014 | — |
| −2 | K151189 | Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System | Devon Medical Products | 2015 | — |
| −1 | K180389 | Venera 508 Deep Vein Thrombosis (DVT) Prevention System | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | 2018 | — |
| 0 (this device) | K183349 | AeroDVx System | Sun Scientific, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K180389 | Venera 508 Deep Vein Thrombosis (DVT) Prevention SystemSummary page 6…nder k070457, which has been on the market for years and has had no safety issues. The Venera 508 DVT Prevention Therapy System has been FDA approved under k180389, and has had no safety issues. Technological Characteristics: Sun Scientific believes that the subject device is substanti… | 2018 |
| † | K070457 | Sun Scientific LLC-Leg Compressor and Pfab | 2007 |
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.
What does this lineage say?
- The line of descent spans 27 years and passes through 8 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 18 ancestors have a recall of any class.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 AeroDVx ™ System is comprised of a gradient compression sleeve, portable intermittent pneumatic pump and hand pump designed to provide static or intermittent pneumatic compression to the calf and foot, in both the hospital and outpatient setting. It is intended to provide treatment for:
1. DVT Prophylaxis
2. Enhancement of blood circulation
3. Reduction of post-operative pain and swelling
4. Reduction of wound-healing time
5. Stasis dermatitis
6. Treatment and assistance of healing cutaneous ulceration
7. Venous stasis ulcers
8. Leg ulcers
9. Chronic venous insufficiency
10. Reduction of edema
11. Lymphedema
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183349 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183349: AeroDVx System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183349
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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