510(k) · Cleared
ClearedPhlebopress Model 601A Compression Therapy Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mego Afek · JOW Sleeve, Limb, Compressible
Cleared on Nov 21, 2007 as substantially equivalent to K060220 (Mego Afek, 2006) and 2 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Nov 21, 2007
- Review
- 90 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K961166 (1996). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK961166 Flowtron Excel PumpHne Healthcare, Inc. · 1996
- This deviceK072372 Phlebopress Model 601A Compression Therapy DeviceMego Afek · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961166 | Flowtron Excel Pump | Hne Healthcare, Inc. | 1996 | — |
| 0 (this device) | K072372 | Phlebopress Model 601A Compression Therapy Device | Mego Afek | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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? (3)
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 |
|---|---|---|---|
| * | K060220 | PBS Model 701A Compression Therapy DeviceSummary page 1…on Therapy Device is substantially equivalent to a combination of the following predicate devices: - PhleboPress Model 701A (K060220) manufactured also by Mego Afek, Ltd (Israel). PhleboPress Model 701A is a compressible… | 2006 |
| * | K961166 | Flowtron Excel PumpSummary page 2…limb sleeve, similar to the Model 601 Compression Therapy Device. - Flowtron Excel Model AC550 (K961166), manufactured by Huntleigh Healthcare Inc. - Flowtron Universal Model AC600 (KO107… | 1996 |
| * | K010744 | Flowtron Universal, Model AC600 | 2002 |
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?
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K060220.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
Prevention of Deep Vein Thrombosis (DVT) in susceptible patients.
Reduction of pain and swelling after injury and surgery.
Enhancement of venous and arterial circulation.
Prevention of venous stasis.
Assist healing of cutaneous ulcers.
Reduction of compartmental pressures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072372 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072372: Phlebopress Model 601A Compression Therapy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072372
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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