510(k) · Cleared
ClearedKendall SCD Sleeves (Extra Large Knee, Extra Large Thigh), Kendall SCD Lexpres Sleeves (Extra Large Knee, Extra Large
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tyco Healthcare/Kendall · JOW Sleeve, Limb, Compressible
Cleared on Oct 13, 2005 as substantially equivalent to K781357 (Kendall Research Center, 1978) after a 100-day review. Its family tree reaches back 1 generation to 1978. 4 later devices descend from it.
- Decided
- Oct 13, 2005
- Review
- 100 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K781357 (1978). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK781357 T.E.D. Sequential Compression SleevesKendall Research Center · 1978 · Recalled
- This deviceK051805 Kendall SCD Sleeves (Extra Large Knee, Extra Large Thigh), Kendall…Tyco Healthcare/Kendall · 2005
- Descendant · cites it directly · 2 of its ownK140813 Reprocessed Kendall SCD Express Compression SleevesCovidien · 2014
- Descendant · 2 generations on · 1 of its ownK161105 Reprocessed Compression GarmentsCovidien · 2016
- Descendant · 3 generations on · 0 of its ownK163620 Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed…Covidien · 2017
- Descendant · cites it directly · 0 of its ownK100306 Kendall SCD Sequential Compression Comfort SleevesCovidien · 2010
Most influential descendants
Showing 4 of 4 · See all- K140813Reprocessed Kendall SCD Express Compression SleevesCovidien · 2014 · cites it directly2descendants
- K161105Reprocessed Compression GarmentsCovidien · 2016 · 2 generations on1descendant
- K163620Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort…Covidien · 2017 · 3 generations on0descendants
- K100306Kendall SCD Sequential Compression Comfort SleevesCovidien · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K781357 | T.E.D. Sequential Compression Sleeves | Kendall Research Center | 1978 | 1 |
| 0 (this device) | K051805 | Kendall SCD Sleeves (Extra Large Knee, Extra Large Thigh), Kendall SCD Lexpres… | Tyco Healthcare/Kendall | 2005 | — |
| +1 | K140813 | Reprocessed Kendall SCD Express Compression Sleeves | Covidien | 2014 | — |
| +2 | K161105 | Reprocessed Compression Garments | Covidien | 2016 | — |
| +3 | K163620 | Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD… | Covidien | 2017 | — |
| +1 | K100306 | Kendall SCD Sequential Compression Comfort Sleeves | Covidien | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K781357 | T.E.D. Sequential Compression SleevesSummary page 5…ially equivalent in intended use, design, function, composition and mode of operation to the currently marketed Kendall Sequential Compression Sleeves (K781357). 4. Device Description Kendall SCDTh and SCD Express" Sleeves (Extra Large Knee, Extra Large Thigh) are… | 1978 |
What descends from it? (4)
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?
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 Kendall SCD® 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 (DVT) and Pulmonary Embolism (PE).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051805 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051805: Kendall SCD Sleeves (Extra Large Knee, Extra Large Thigh), Kendall SCD Lexpres Sleeves (Extra Large Knee, Extra Large.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051805
Report an extraction error
Are you the manufacturer?
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