510(k) · Cleared
ClearedSequential Compression System (SCD600)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Comen Medical Instruments Co.,Ltd · JOW Sleeve, Limb, Compressible
Cleared on Dec 8, 2025 as substantially equivalent to K120944 (Covidien, 2012) after a 319-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Dec 8, 2025
- Review
- 319 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K953648 (1996). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK953648 A-V Impulse System Model 6060Novamedix, Ltd. · 1996
- 3 generations backK040511 SCD Express Portable Compression SystemTyco Healthcare/Kendall · 2004
- 2 generations backK102737 Kendall SCD 700 Sequential Compression ControllerCovidien, LLC · 2010
- 1 generation backK120944 Kendall SCD 700 Sequential Compression ControllerCovidien · 2012
- This deviceK250190 Sequential Compression System (SCD600)Shenzhen Comen Medical Instruments Co.,Ltd · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953648 | A-V Impulse System Model 6060 | Novamedix, Ltd. | 1996 | — |
| −3 | K040511 | SCD Express Portable Compression System | Tyco Healthcare/Kendall | 2004 | — |
| −2 | K102737 | Kendall SCD 700 Sequential Compression Controller | Covidien, LLC | 2010 | — |
| −1 | K120944 | Kendall SCD 700 Sequential Compression Controller | Covidien | 2012 | — |
| 0 (this device) | K250190 | Sequential Compression System (SCD600) | Shenzhen Comen Medical Instruments Co.,Ltd | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 |
|---|---|---|---|
| * | K120944 | Kendall SCD 700 Sequential Compression ControllerSummary page 5…b, Compressible 510(K) Number: K250190, Traditional Regulation Number: 870.5800 Product Code(s): JOW Predicate #: K120944 Predicate Trade Name: Kendall SCD 700 Sequential Compression Controller Predicate Product Code: JOW 3. Device Des… | 2012 |
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 29 years and passes through 5 companies; a new generation was cleared every 8.4 years on median.
- None of the 5 ancestors has a recall.
- 3 other devices also cite its predicate K120944.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 SCD600 Sequential Compression System (hereby referenced as "SCD600") is designed to increase the flow rate of the patient's venous blood in order to prevent deep vein thrombosis and pulmonary embolism and treat limb edema via intermittent pneumatic compression. The SCD600 is intended for use only in professional healthcare facilities by medical staff as part of a prescribed plan of care.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250190 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250190: Sequential Compression System (SCD600).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250190
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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