510(k) · Cleared
ClearedSequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
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 May 14, 2021 as substantially equivalent to K142640 (Bio Compression Systems, Inc., 2014) after a 92-day review. Its family tree reaches back 2 generations to 2005. 2 later devices descend from it.
- Decided
- May 14, 2021
- Review
- 92 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K043423 (2005). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK043423 Model SC-3008 Sequential CirculatorBio Compression Systems, Inc. · 2005
- 1 generation backK142640 Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL…Bio Compression Systems, Inc. · 2014
- This deviceK210417 Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL…Bio Compression Systems, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK261807 Sequential Circulator (SC-4004-DL, SC-4008-DL)Bio Compression Systems, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK203746 Venen-trainer (Model: FM150, SFM90)Shenzhen Pango Electronic Co., Ltd. · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K043423 | Model SC-3008 Sequential Circulator | Bio Compression Systems, Inc. | 2005 | — |
| −1 | K142640 | Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial… | Bio Compression Systems, Inc. | 2014 | — |
| 0 (this device) | K210417 | Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL… | Bio Compression Systems, Inc. | 2021 | — |
| +1 | K261807 | Sequential Circulator (SC-4004-DL, SC-4008-DL) | Bio Compression Systems, Inc. | 2026 | — |
| +1 | K203746 | Venen-trainer (Model: FM150, SFM90) | Shenzhen Pango Electronic Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (1)
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 |
|---|---|---|---|
| * | K142640 | Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model…Summary page 4….5800) Product Code JOW Class Class II III. PREDICATE DEVICE Sequential Circulator models SC-3004-DL and SC-3008-DL (K142640). Reference devices K043423, K122112, K131306, K150953, K171793, K182003, and K203178 are mentioned. Section 5… | 2014 |
| † | K043423 | Model SC-3008 Sequential Circulator | 2005 |
| † | K122112 | 2004-OC Massage System, 2008-OC Massage System | 2013 |
| † | K131306 | IC-1545-DL Multi Flo DVT Combo Intermittent Pneumatic Compression Device | 2013 |
| † | K150953 | Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC | 2015 |
| † | K171793 | Sequential Circulator SC-2004FC-OC | 2017 |
| † | K182003 | Lympha Press Optimal Plus | 2019 |
| † | K203178 | Flexitouch Plus System | 2020 |
What descends from it? (2)
2 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 16 years and passes through 1 company; a new generation was cleared every 9.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K261807 (Bio Compression Systems, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K142640.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Bio Compression Systems' Sequential Circulators are sequential, pneumatic compression devices intended for either primary or adjunctive treatment of lymphedema, peripheral edema, lipedema, venous insufficiency, and venous stasis ulcers. Sequential Circulators are also intended for the prophylaxis of deep vein thrombosis (DVT). Intended for use in a home or healthcare setting.
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/K210417 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210417: Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210417
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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