510(k) · Cleared
ClearedModel SC-3008 Sequential Circulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio Compression Systems, Inc. · JOW Sleeve, Limb, Compressible
Cleared on Feb 1, 2005 after a 50-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 101 later devices descend from it.
- Decided
- Feb 1, 2005
- Review
- 50 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 1
101 later devices descend from it, 9 citing it directly.
- This deviceK043423 Model SC-3008 Sequential CirculatorBio Compression Systems, Inc. · 2005
- Descendant · cites it directly · 52 of its ownK061866 Nanotherm, Vascutherm and Prothermo Therapy WrapsThermotek, Inc. · 2006
- Descendant · 2 generations on · 25 of its ownK103187 Tripleplay-VT Vascular Therapy SystemWildcat Medical, Inc. · 2011
- Descendant · 3 generations on · 22 of its ownK133274 Vena ProInnovamed Health, LLC · 2014
- Descendant · cites it directly · 22 of its ownK100446 Circuflow 5100 Sequential Compression DeviceDevon Medical, Inc. · 2010
- Descendant · cites it directly · 22 of its ownK061857 Model Multi-Flo IC-1545-KT/-F Intermittent CirculatorBio Compression Systems, Inc. · 2006
Showing 5 of 101 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 101 · See all- K061866Nanotherm, Vascutherm and Prothermo Therapy WrapsThermotek, Inc. · 2006 · cites it directly52descendants
- K103187Tripleplay-VT Vascular Therapy SystemWildcat Medical, Inc. · 2011 · 2 generations on25descendants
- K133274Vena ProInnovamed Health, LLC · 2014 · 3 generations on22descendants
- K100446Circuflow 5100 Sequential Compression DeviceDevon Medical, Inc. · 2010 · cites it directly22descendants
- K061857Model Multi-Flo IC-1545-KT/-F Intermittent CirculatorBio Compression Systems, Inc. · 2006 · cites it directly22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K043423 | Model SC-3008 Sequential Circulator | Bio Compression Systems, Inc. | 2005 | — |
| +1 | K061866 | Nanotherm, Vascutherm and Prothermo Therapy Wraps | Thermotek, Inc. | 2006 | — |
| +2 | K103187 | Tripleplay-VT Vascular Therapy System | Wildcat Medical, Inc. | 2011 | — |
| +3 | K133274 | Vena Pro | Innovamed Health, LLC | 2014 | — |
| +1 | K100446 | Circuflow 5100 Sequential Compression Device | Devon Medical, Inc. | 2010 | — |
| +1 | K061857 | Model Multi-Flo IC-1545-KT/-F Intermittent Circulator | Bio Compression Systems, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 6 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 7 | 0 |
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 6 | 0 |
| 2018 | 5 | 0 |
| 2019 | 8 | 0 |
| 2020 | 7 | 0 |
| 2021 | 11 | 0 |
| 2022 | 4 | 0 |
| 2023 | 5 | 0 |
| 2024 | 8 | 0 |
| 2025 | 6 | 0 |
| 2026 | 7 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K810335 | FDA’s K810335 is Respirizer Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1981 |
| * | — | The Sequential Circulator Named without a submission number |
What descends from it? (101)
See all 1019 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061866 | Nanotherm, Vascutherm and Prothermo Therapy Wraps | 2006 | 52 |
| K100446 | Circuflow 5100 Sequential Compression Device | 2010 | 22 |
| K061857 | Model Multi-Flo IC-1545-KT/-F Intermittent Circulator | 2006 | 22 |
| K062818 | Flexitouch System | 2006 | 10 |
| K142640 | Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model… | 2014 | 7 |
| K053225 | Cellu M6 Keymodule I | 2006 | 3 |
| K150953 | Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC | 2015 | 1 |
| K110276 | Powerpress Unit | 2011 | 0 |
| K071763 | Amadeus Adaptive Compression Therapy | 2008 | 0 |
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?
- Of its descendants, K061866 (Thermotek, Inc., 2006) has gone furthest, with 52 descendants of its own.
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 Model SC-3008 Sequential Circulator 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/K043423 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043423: Model SC-3008 Sequential Circulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043423
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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