510(k) · Cleared
ClearedProair 3000 Compression System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Compression Systems (Dbn), Ltd. · JOW Sleeve, Limb, Compressible
Cleared on May 19, 2000 as substantially equivalent to K942664 (The Kendal Co., 1995) and 3 other predicates after a 196-day review. Its family tree reaches back 2 generations to 1995. 31 later devices descend from it.
- Decided
- May 19, 2000
- Review
- 196 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K944567 (1995). 5 ancestors in all, the oldest K915092 (1992). 31 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK944567 Cowboy XKinetic Concepts, Inc. · 1995 · Recalled
- 1 generation backK981311 Cowboy XVKci New Technologies, Inc. · 1999
- This deviceK993758 Proair 3000 Compression SystemMedical Compression Systems (Dbn), Ltd. · 2000
- Descendant · cites it directly · 30 of its ownK060146 Activecare ++ SystemMedical Compression Systems (Dbn), Ltd. · 2006 · Recalled
- Descendant · 2 generations on · 10 of its ownK062818 Flexitouch SystemTactile Systems Technology, Inc. · 2006
- Descendant · 3 generations on · 9 of its ownK120972 Flexitouch SystemTactile Systems Technology, Inc. · 2012
- Descendant · 2 generations on · 9 of its ownK110159 Activecare SFTMedical Compression Systems (Dbn), Ltd. · 2011
- Descendant · 3 generations on · 8 of its ownK153311 Flexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical) · 2016
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K060146Activecare ++ SystemMedical Compression Systems (Dbn), Ltd. · 2006 · cites it directly30descendants
- K062818Flexitouch SystemTactile Systems Technology, Inc. · 2006 · 2 generations on10descendants
- K120972Flexitouch SystemTactile Systems Technology, Inc. · 2012 · 3 generations on9descendants
- K110159Activecare SFTMedical Compression Systems (Dbn), Ltd. · 2011 · 2 generations on9descendants
- K153311Flexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical) · 2016 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944567 | Cowboy X | Kinetic Concepts, Inc. | 1995 | 1 |
| −1 | K981311 | Cowboy XV | Kci New Technologies, Inc. | 1999 | — |
| 0 (this device) | K993758 | Proair 3000 Compression System | Medical Compression Systems (Dbn), Ltd. | 2000 | — |
| +1 | K060146 | Activecare ++ System | Medical Compression Systems (Dbn), Ltd. | 2006 | 1 |
| +2 | K062818 | Flexitouch System | Tactile Systems Technology, Inc. | 2006 | — |
| +3 | K120972 | Flexitouch System | Tactile Systems Technology, Inc. | 2012 | — |
| +2 | K110159 | Activecare SFT | Medical Compression Systems (Dbn), Ltd. | 2011 | — |
| +3 | K153311 | Flexitouch System | Tactile Systems Technology, Inc. (Dba Tactile Medical) | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2026 | 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? (4)
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 |
|---|---|---|---|
| * | K942664 | Kendall Model 6325 SCD Sequel Compression SystemSummary page 2…00) and they are reviewed by the Cardiovascular Panel. Predicate Device: e Kendall Model 6325 SCD Sequel Compression System (Kendall Co.), cleared under K942664 * Talley TM300 Sequential Multicom Compression System (Progressive Medical Technology, Inc.) cleared under K915092 * Jobst Extr… | 1995 |
| * | K915092 | Talley TM300 Sequential Multicom Compression SystSummary page 2…equel Compression System (Kendall Co.), cleared under K942664 * Talley TM300 Sequential Multicom Compression System (Progressive Medical Technology, Inc.) cleared under K915092 * Jobst Extremity Pump System 7500 (Jobst Institute, Inc.) cleared under K921562 e Cowboy XV [PlexiPulse®] (KCI New Technologie… | 1992 |
| * | K921562 | Jobst Extremity Pump System 7500Summary page 2…ential Multicom Compression System (Progressive Medical Technology, Inc.) cleared under K915092 * Jobst Extremity Pump System 7500 (Jobst Institute, Inc.) cleared under K921562 e Cowboy XV [PlexiPulse®] (KCI New Technologies, Inc.) cleared under K981311 Performahce Standards: No performance standards h… | 1992 |
| * | K981311 | Cowboy XVSummary page 2…red under K915092 * Jobst Extremity Pump System 7500 (Jobst Institute, Inc.) cleared under K921562 e Cowboy XV [PlexiPulse®] (KCI New Technologies, Inc.) cleared under K981311 Performahce Standards: No performance standards have been established for such device under Section 514 of the Federal Food, Dr… | 1999 |
What descends from it? (31)
See all 311 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060146 | Activecare ++ System | 2006 | 30 |
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 5 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K060146 (Medical Compression Systems (Dbn), Ltd., 2006) has gone furthest, with 30 descendants of its own.
- 3 other devices also cite its predicate K942664.
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 ‘ProAir 3000 is a prescriptive device that induces controlled compression of the calf, the foot or combined compression of both.
The ProAir 3000 is intended for use by patients and medical professionals in treating many conditions, such as:
- prevention of deep vein thrombosis (DVT)
- enhancement of blood circulation
« reduction of post-operative pain and swelling
« reduction of wound-healing time
+ stasis dermatitis
- treatment and assist healing of cutaneous ulceration
+ venous stasis ulcers
+ legulcers
« chronic venous insufficiencies
+ reduction of edema
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/K993758 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993758: Proair 3000 Compression System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993758
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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