510(k) · Cleared
ClearedKendall SCD Sequential Compression Comfort Sleeves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien · JOW Sleeve, Limb, Compressible
Cleared on May 4, 2010 as substantially equivalent to K040511 (Tyco Healthcare/Kendall, 2004) and 2 other predicates after a 90-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- May 4, 2010
- Review
- 90 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K953648 (1996). 6 ancestors in all, the oldest K781357 (1978). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953648 | A-V Impulse System Model 6060 | Novamedix, Ltd. | 1996 | — |
| −1 | K040511 | SCD Express Portable Compression System | Tyco Healthcare/Kendall | 2004 | — |
| 0 (this device) | K100306 | Kendall SCD Sequential Compression Comfort Sleeves | Covidien | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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? (3)
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 |
|---|---|---|---|
| * | K040511 | SCD Express Portable Compression SystemSummary page 1…d Device The proposed devices, Sequential Compression Comfort Sleeves, are identical in intended use, function and mode of operation to the SOID Express System Sleeves (K04051 1); SOD Express Tear-Away Sleeves (K040649) and SOID Large/X-Large Knee and Thigh Sleeves (KO51805). 4. Device Description Th… | 2004 |
| * | K040649 | Kendall SCD Express Kambia Thigh Length Tearaway SleeveSummary page 1…Compression Comfort Sleeves, are identical in intended use, function and mode of operation to the SOID Express System Sleeves (K04051 1); SOD Express Tear-Away Sleeves (K040649) and SOID Large/X-Large Knee and Thigh Sleeves (KO51805). 4. Device Description The proposed devices, Sequential Compressio… | 2004 |
| * | K051805 | Kendall SCD Sleeves (Extra Large Knee, Extra Large Thigh), Kendall SCD Lexpres Sleeves…Summary page 2…use, function and mode of operation to the SOID Express System Sleeves (K04051 1); SOD Express Tear-Away Sleeves (K040649) and SOD Large/X-Large Knee and Thigh Sleeves (K051805). The predicate SOD Sleeves are constructed of two layers of non-woven polyester laminated to a thin film of PVC that are welded… | 2005 |
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 14 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 8 other devices also cite its predicate K040511.
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 Kendall SOD Compression System is designed to increase venous blood flow in at risk patients, including bariatric and morbidly obese patients, in order to help prevent deep vein thrombosis and pulmonary embolism.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100306 · printed Nov 3, 2026
Cite this page
510(k) Report. “K100306: Kendall SCD Sequential Compression Comfort Sleeves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K100306
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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