510(k) · Cleared
ClearedCircuflow 5208 Sequential Compression Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Devon Medical, Inc. · JOW Sleeve, Limb, Compressible
Cleared on Feb 14, 2013 as substantially equivalent to K101523 (Devon Medical, Inc., 2010) and 3 other predicates after a 79-day review. Its family tree reaches back 4 generations to 1981. 12 later devices descend from it.
- Decided
- Feb 14, 2013
- Review
- 79 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K810338 (1981). 10 ancestors in all. 12 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK810338 Lympha PressMego Afek · 1981
- 3 generations backK013331 Lympha Press Plus DeviceMego Afek · 2001
- 2 generations backK082149 Lympha Press Optimal, Model# 1201APMego Afek AC, Ltd. · 2008
- 1 generation backK100677 Lympha Press 201MAX, Model 201MAXMego Afek AC, Ltd. · 2010
- This deviceK123647 Circuflow 5208 Sequential Compression DeviceDevon Medical, Inc. · 2013
- Descendant · cites it directly · 4 of its ownK143185 entré Model PD08-UTactile Systems Technology, Inc. · 2015
- Descendant · cites it directly · 3 of its ownK172770 AIROS 6 Sequential Compression DeviceAiros Medical, Inc. · 2018
- Descendant · 2 generations on · 2 of its ownK193069 AIROS 6 Sequential Compression DeviceAiros Medical, Inc. · 2019
- Descendant · cites it directly · 2 of its ownK172779 AIROS 8 Sequential Compression DeviceAiros Medical, Inc. · 2018
- Descendant · 3 generations on · 1 of its ownK223195 AIROS 6P Sequential Compression DeviceAiros Medical, Inc. · 2022
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K143185entré Model PD08-UTactile Systems Technology, Inc. · 2015 · cites it directly4descendants
- K172770AIROS 6 Sequential Compression DeviceAiros Medical, Inc. · 2018 · cites it directly3descendants
- K193069AIROS 6 Sequential Compression DeviceAiros Medical, Inc. · 2019 · 2 generations on2descendants
- K172779AIROS 8 Sequential Compression DeviceAiros Medical, Inc. · 2018 · cites it directly2descendants
- K223195AIROS 6P Sequential Compression DeviceAiros Medical, Inc. · 2022 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K810338 | Lympha Press | Mego Afek | 1981 | — |
| −3 | K013331 | Lympha Press Plus Device | Mego Afek | 2001 | — |
| −2 | K082149 | Lympha Press Optimal, Model# 1201AP | Mego Afek AC, Ltd. | 2008 | — |
| −1 | K100677 | Lympha Press 201MAX, Model 201MAX | Mego Afek AC, Ltd. | 2010 | — |
| 0 (this device) | K123647 | Circuflow 5208 Sequential Compression Device | Devon Medical, Inc. | 2013 | — |
| +1 | K143185 | entré Model PD08-U | Tactile Systems Technology, Inc. | 2015 | — |
| +1 | K172770 | AIROS 6 Sequential Compression Device | Airos Medical, Inc. | 2018 | — |
| +2 | K193069 | AIROS 6 Sequential Compression Device | Airos Medical, Inc. | 2019 | — |
| +1 | K172779 | AIROS 8 Sequential Compression Device | Airos Medical, Inc. | 2018 | — |
| +3 | K223195 | AIROS 6P Sequential Compression Device | Airos Medical, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 2 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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 |
|---|---|---|---|
| * | K101523 | Circuflow 5200 Sequential Compression DeviceSummary page 1…edicate Device Manufacturer.-'' 510(k)# CircuFlow 5200 Devon Medical, Inc. K101523 Lymphapress Model 201 MAX Mego Afek Ltd K1 00677 Proact 1… | 2010 |
| * | K100677 | Lympha Press 201MAX, Model 201MAXSummary page 1…cuFlow 5200 Devon Medical, Inc. K101523 Lymphapress Model 201 MAX Mego Afek Ltd K1 00677 Proact 1 Proact Company K003909 Circu Flow 5100… | 2010 |
| * | K003909 | Proact 1Summary page 1…hapress Model 201 MAX Mego Afek Ltd K1 00677 Proact 1 Proact Company K003909 Circu Flow 5100 Devon Medical, Inc. K100446 Device Description The CircuFlow 520… | 2001 |
| * | K100446 | Circuflow 5100 Sequential Compression DeviceSummary page 1…act 1 Proact Company K003909 Circu Flow 5100 Devon Medical, Inc. K100446 Device Description The CircuFlow 5208 is a digitally controlled sequential pneumatic compression device designed to apply compre… | 2010 |
What descends from it? (12)
See all 123 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 32 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K143185 (Tactile Systems Technology, Inc., 2015) has gone furthest, with 4 descendants of its own.
- 4 other devices also cite its predicate K101523.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 CircuFlow 5208 Sequential Compression Device is a compression device based on sequential pneumatic compression technique which is intended for the treatment of the following conditions:
- Lymphedema
- Venous stasis ulcers*
- Venous insufficiency
- Peripheral edema
The device is intended for home and hospital use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123647 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123647: Circuflow 5208 Sequential Compression Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123647
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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