510(k) · Cleared
Recalled · Class II · 2019T.E.D. Sequential Compression Sleeves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kendall Research Center · JOW Sleeve, Limb, Compressible
Cleared on Sep 20, 1978 after a 43-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 15 later devices descend from it. It has been recalled once.
- Decided
- Sep 20, 1978
- Review
- 43 days
- Class
- Class II
- Product code
- JOW
- Recalls
- 1
- Predicates
- 0
15 later devices descend from it, 5 citing it directly.
- This deviceK781357 T.E.D. Sequential Compression SleevesKendall Research Center · 1978
- Descendant · cites it directly · 5 of its ownK040649 Kendall SCD Express Kambia Thigh Length Tearaway SleeveTyco Healthcare · 2004
- Descendant · cites it directly · 4 of its ownK051805 Kendall SCD Sleeves (Extra Large Knee, Extra Large Thigh), Kendall…Tyco Healthcare/Kendall · 2005
- Descendant · 2 generations on · 3 of its ownK053575 Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot…Hygia Health Services, Inc. · 2006
- Descendant · cites it directly · 3 of its ownK012403 Vanguard Reprocessed Compression GarmentVanguard Medical Concepts, Inc. · 2001 · Recalled
- Descendant · cites it directly · 2 of its ownK140813 Reprocessed Kendall SCD Express Compression SleevesCovidien · 2014
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K040649Kendall SCD Express Kambia Thigh Length Tearaway SleeveTyco Healthcare · 2004 · cites it directly5descendants
- K051805Kendall SCD Sleeves (Extra Large Knee, Extra Large Thigh), Kendall SCD Lexpres Sleeves…Tyco Healthcare/Kendall · 2005 · cites it directly4descendants
- K053575Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot CuffsHygia Health Services, Inc. · 2006 · 2 generations on3descendants
- K012403Vanguard Reprocessed Compression GarmentVanguard Medical Concepts, Inc. · 2001 · cites it directly3descendants
- K140813Reprocessed Kendall SCD Express Compression SleevesCovidien · 2014 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K781357 | T.E.D. Sequential Compression Sleeves | Kendall Research Center | 1978 | — |
| +1 | K040649 | Kendall SCD Express Kambia Thigh Length Tearaway Sleeve | Tyco Healthcare | 2004 | — |
| +1 | K051805 | Kendall SCD Sleeves (Extra Large Knee, Extra Large Thigh), Kendall SCD Lexpres… | Tyco Healthcare/Kendall | 2005 | — |
| +2 | K053575 | Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot Cuffs | Hygia Health Services, Inc. | 2006 | — |
| +1 | K012403 | Vanguard Reprocessed Compression Garment | Vanguard Medical Concepts, Inc. | 2001 | 6 |
| +1 | K140813 | Reprocessed Kendall SCD Express Compression Sleeves | Covidien | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (15)
See all 155 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040649 | Kendall SCD Express Kambia Thigh Length Tearaway Sleeve | 2004 | 5 |
| K051805 | Kendall SCD Sleeves (Extra Large Knee, Extra Large Thigh), Kendall SCD Lexpres Sleeves… | 2005 | 4 |
| K012403 | Vanguard Reprocessed Compression Garment | 2001 | 3 |
| K140813 | Reprocessed Kendall SCD Express Compression Sleeves | 2014 | 2 |
| K012597 | Sterilmed Reprocessed Compression Sleeves | 2002 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 15, 2019 | Class II | Z-1041-2019 | Under Investigation by firm | The product does not meet sterility requirements. Product labeled as sterile was distributed without undergoing sterilization prior to distribution. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K040649 (Tyco Healthcare, 2004) has gone furthest, with 5 descendants of its own.
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 | — |
https://510kreport.com/device/K781357 · printed Nov 6, 2026
Cite this page
510(k) Report. “K781357: T.E.D. Sequential Compression Sleeves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K781357
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026