510(k) · Cleared
ClearedReprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression 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 Jan 19, 2017 as substantially equivalent to K161105 (Covidien, 2016) after a 28-day review. Its family tree reaches back 4 generations to 1978.
- Decided
- Jan 19, 2017
- Review
- 28 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K781357 (1978). No later device cites it as a predicate yet.
- Root · 4 generations backK781357 T.E.D. Sequential Compression SleevesKendall Research Center · 1978 · Recalled
- 3 generations backK051805 Kendall SCD Sleeves (Extra Large Knee, Extra Large Thigh), Kendall…Tyco Healthcare/Kendall · 2005
- 2 generations backK140813 Reprocessed Kendall SCD Express Compression SleevesCovidien · 2014
- 1 generation backK161105 Reprocessed Compression GarmentsCovidien · 2016
- This deviceK163620 Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed…Covidien · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K781357 | T.E.D. Sequential Compression Sleeves | Kendall Research Center | 1978 | 1 |
| −3 | K051805 | Kendall SCD Sleeves (Extra Large Knee, Extra Large Thigh), Kendall SCD Lexpres… | Tyco Healthcare/Kendall | 2005 | — |
| −2 | K140813 | Reprocessed Kendall SCD Express Compression Sleeves | Covidien | 2014 | — |
| −1 | K161105 | Reprocessed Compression Garments | Covidien | 2016 | — |
| 0 (this device) | K163620 | Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD… | Covidien | 2017 | — |
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 |
|---|---|---|---|
| * | K161105 | Reprocessed Compression GarmentsSummary page 5…21 CFR 870.5800 Product Code: JOW Classification: Class II 3. Predicate Devices: Covidien Reprocessed Compression Garments (K161105) 4. Device Description: The Reprocessed Compression Sleeves are the sleeve component of the pneumatic compression… | 2016 |
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 39 years and passes through 3 companies; a new generation was cleared every 8.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
Reprocessed SCD™ Express Compression Sleeves (Large and X-Large Sizes) & Reprocessed SCD™ Comfort Compression Sleeves (All Sizes)
The Kendall SCD 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.
Reprocessed SCD™ Express Compression Sleeves (Small and Medium Sizes)
The Kendall SCD Compression System is designed 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/K163620 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163620: Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163620
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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