510(k) · Cleared
ClearedCircuflow 5100 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 Mar 5, 2010 as substantially equivalent to K043423 (Bio Compression Systems, Inc., 2005) and 1 other predicate after a 16-day review. Its family tree reaches back 1 generation to 2005. 22 later devices descend from it.
- Decided
- Mar 5, 2010
- Review
- 16 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K043423 (2005). 2 ancestors in all. 22 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK043423 Model SC-3008 Sequential CirculatorBio Compression Systems, Inc. · 2005
- This deviceK100446 Circuflow 5100 Sequential Compression DeviceDevon Medical, Inc. · 2010
- Descendant · cites it directly · 21 of its ownK101523 Circuflow 5200 Sequential Compression DeviceDevon Medical, Inc. · 2010
- Descendant · cites it directly · 12 of its ownK123647 Circuflow 5208 Sequential Compression DeviceDevon Medical, Inc. · 2013
- Descendant · cites it directly · 6 of its ownK123959 Circuflow 5150Devon Medical, Inc. · 2013
- Descendant · 2 generations on · 4 of its ownK143185 entré Model PD08-UTactile Systems Technology, Inc. · 2015
- Descendant · 2 generations on · 3 of its ownK183631 medi pneumatic compression system (pcs) – brio (Model 651)Medi USA, LP · 2019
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K101523Circuflow 5200 Sequential Compression DeviceDevon Medical, Inc. · 2010 · cites it directly21descendants
- K123647Circuflow 5208 Sequential Compression DeviceDevon Medical, Inc. · 2013 · cites it directly12descendants
- K123959Circuflow 5150Devon Medical, Inc. · 2013 · cites it directly6descendants
- K143185entré Model PD08-UTactile Systems Technology, Inc. · 2015 · 2 generations on4descendants
- K183631medi pneumatic compression system (pcs) – brio (Model 651)Medi USA, LP · 2019 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K043423 | Model SC-3008 Sequential Circulator | Bio Compression Systems, Inc. | 2005 | — |
| 0 (this device) | K100446 | Circuflow 5100 Sequential Compression Device | Devon Medical, Inc. | 2010 | — |
| +1 | K101523 | Circuflow 5200 Sequential Compression Device | Devon Medical, Inc. | 2010 | — |
| +1 | K123647 | Circuflow 5208 Sequential Compression Device | Devon Medical, Inc. | 2013 | — |
| +1 | K123959 | Circuflow 5150 | Devon Medical, Inc. | 2013 | — |
| +2 | K143185 | entré Model PD08-U | Tactile Systems Technology, Inc. | 2015 | — |
| +2 | K183631 | medi pneumatic compression system (pcs) – brio (Model 651) | Medi USA, LP | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K043423 | Model SC-3008 Sequential CirculatorSummary page 1…anufacturer 510(k)# SC-3008 Sequential Circulator Bio Compression Systems Inc. K043423 GS-128 Sequential Compression MedMark Technologies K050584 Syst… | 2005 |
| * | K050584 | GS-128 Gradient Compression SystemSummary page 1…s Inc. K043423 GS-128 Sequential Compression MedMark Technologies K050584 System _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Device Descript… | 2005 |
What descends from it? (22)
See all 223 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?
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 5100 Sequential Compression Device is a manual, sequential, pneumatic compression device, intended for the primary or adjunctive treatment of primary or secondary lymphedema. The device is also intended for the additional or alternate treatment of venous insufficiency, and chronic venous stasis ulcers associated with venous insufficiency, as well as general treatment of swelling of the extremities.
The device is intended for home or hospital use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100446 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100446: Circuflow 5100 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/K100446
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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