510(k) · Cleared
ClearedKendall SCD Express Kambia Thigh Length Tearaway Sleeve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tyco Healthcare · JOW Sleeve, Limb, Compressible
Cleared on Jul 15, 2004 as substantially equivalent to K781357 (Kendall Research Center, 1978) after a 126-day review. Its family tree reaches back 1 generation to 1978. 5 later devices descend from it.
- Decided
- Jul 15, 2004
- Review
- 126 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K781357 (1978). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK781357 T.E.D. Sequential Compression SleevesKendall Research Center · 1978 · Recalled
- This deviceK040649 Kendall SCD Express Kambia Thigh Length Tearaway SleeveTyco Healthcare · 2004
- Descendant · cites it directly · 3 of its ownK053575 Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot…Hygia Health Services, Inc. · 2006
- Descendant · 2 generations on · 1 of its ownK090074 Hygia Health Services Reprocessed Compression Sleeves / Foot CuffsHygia Health Services, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK101330 Midwest Reprocessing Center Reprocessed SCD Express Sleeves/ Foot…Midwest Reprocessing Center, LLC · 2010
- Descendant · 3 generations on · 0 of its ownK101702 Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot CuffsMidwest Reprocessing Center, LLC · 2010
- Descendant · cites it directly · 0 of its ownK100306 Kendall SCD Sequential Compression Comfort SleevesCovidien · 2010
Most influential descendants
Showing 5 of 5 · See all- K053575Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot CuffsHygia Health Services, Inc. · 2006 · cites it directly3descendants
- K090074Hygia Health Services Reprocessed Compression Sleeves / Foot CuffsHygia Health Services, Inc. · 2009 · 2 generations on1descendant
- K101330Midwest Reprocessing Center Reprocessed SCD Express Sleeves/ Foot Cuffs, Midwest…Midwest Reprocessing Center, LLC · 2010 · cites it directly0descendants
- K101702Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot CuffsMidwest Reprocessing Center, LLC · 2010 · 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) | K040649 | Kendall SCD Express Kambia Thigh Length Tearaway Sleeve | Tyco Healthcare | 2004 | — |
| +1 | K053575 | Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot Cuffs | Hygia Health Services, Inc. | 2006 | — |
| +2 | K090074 | Hygia Health Services Reprocessed Compression Sleeves / Foot Cuffs | Hygia Health Services, Inc. | 2009 | — |
| +1 | K101330 | Midwest Reprocessing Center Reprocessed SCD Express Sleeves/ Foot Cuffs… | Midwest Reprocessing Center, LLC | 2010 | — |
| +3 | K101702 | Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot Cuffs | Midwest Reprocessing Center, LLC | 2010 | — |
| +1 | K100306 | Kendall SCD Sequential Compression Comfort Sleeves | Covidien | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 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 1…IATM Thigh Length TearAway Sleeve, is substantially equivalent in intended use, function and composition to the Kendall T.E.D. Sequential Compression Sleeve (K781357). 4. Device Description The proposed device, Kendall SOD T M Express Tm KAMBIA TM Thigh Length TearAway Sleeve,… | 1978 |
What descends from it? (5)
3 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 proposed device, Kendall SCD Express KAMBIA Thigh Length TearAway Sleeves, are intended to be used with an intermittent pneumatic device to increase venous blood flow in at risk 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/K040649 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040649: Kendall SCD Express Kambia Thigh Length Tearaway Sleeve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040649
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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