510(k) · Cleared
ClearedVenen-trainer (Model: FM150, SFM90)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Pango Electronic Co., Ltd. · JOW Sleeve, Limb, Compressible
Cleared on Nov 10, 2021 as substantially equivalent to K210417 (Bio Compression Systems, Inc., 2021) after a 323-day review. Its family tree reaches back 3 generations to 2005.
- Decided
- Nov 10, 2021
- Review
- 323 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K043423 (2005). No later device cites it as a predicate yet.
- Root · 3 generations backK043423 Model SC-3008 Sequential CirculatorBio Compression Systems, Inc. · 2005
- 2 generations backK142640 Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL…Bio Compression Systems, Inc. · 2014
- 1 generation backK210417 Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL…Bio Compression Systems, Inc. · 2021
- This deviceK203746 Venen-trainer (Model: FM150, SFM90)Shenzhen Pango Electronic Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K043423 | Model SC-3008 Sequential Circulator | Bio Compression Systems, Inc. | 2005 | — |
| −2 | K142640 | Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial… | Bio Compression Systems, Inc. | 2014 | — |
| −1 | K210417 | Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL… | Bio Compression Systems, Inc. | 2021 | — |
| 0 (this device) | K203746 | Venen-trainer (Model: FM150, SFM90) | Shenzhen Pango Electronic Co., Ltd. | 2021 | — |
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 |
|---|---|---|---|
| * | K210417 | Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL… Cleared while this submission was under review Summary page 4…4. Predicate Device Information Sponsor: Bio Compression Systems, Inc. Trade Name: Sequential Circulators Classification Name: Sleeve, Limb, Compressible 510(K) Number: K210417 Review Panel: Cardiovascular Product Code: JOW Regulation Number: 870.5800 Regulation Class: 2 5. Device Description Venen-Train… | 2021 |
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?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 6.5 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K210417.
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?
Venen-trainer (Model: FM150, SFM90) is intended for either primary or adjunctive treatment of lymphedema, peripheral edema, lipedema, venous insufficiency, and venous stasis ulcers. These devices are also intended for the prophylaxis of deep vein thrombosis (DVT).
Intended for use in a home or healthcare setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203746 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203746: Venen-trainer (Model: FM150, SFM90).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203746
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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