510(k) · Cleared
ClearedReprocessed Compression Garments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien · JOW Sleeve, Limb, Compressible
Cleared on Aug 18, 2016 as substantially equivalent to K140813 (Covidien, 2014) after a 121-day review. Its family tree reaches back 3 generations to 1978. 1 later device descends from it.
- Decided
- Aug 18, 2016
- Review
- 121 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K781357 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK781357 T.E.D. Sequential Compression SleevesKendall Research Center · 1978 · Recalled
- 2 generations backK051805 Kendall SCD Sleeves (Extra Large Knee, Extra Large Thigh), Kendall…Tyco Healthcare/Kendall · 2005
- 1 generation backK140813 Reprocessed Kendall SCD Express Compression SleevesCovidien · 2014
- This deviceK161105 Reprocessed Compression GarmentsCovidien · 2016
- Descendant · cites it directly · 0 of its ownK163620 Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed…Covidien · 2017
Most influential descendants
Showing 1 of 1 · See all- K163620Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort…Covidien · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K781357 | T.E.D. Sequential Compression Sleeves | Kendall Research Center | 1978 | 1 |
| −2 | 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 | — |
| 0 (this device) | K161105 | Reprocessed Compression Garments | Covidien | 2016 | — |
| +1 | K163620 | Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD… | Covidien | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K140813 | Reprocessed Kendall SCD Express Compression SleevesSummary page 5…Regulation Number: 21 CFR 876.5800 Product Code: JOW Classification: Class II 3. Predicate Devices: Covidien Reprocessed Compression Garments (K140813) 4. Device Description: The Reprocessed Compression Garment is the sleeve component of the pneumatic compression… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163620 | Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort… | 2017 | 0 |
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 38 years and passes through 3 companies; a new generation was cleared every 8.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K163620 (Covidien, 2017) has gone furthest, with 0 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. 2016, 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?
Compression Garments (Large and X-Large Sizes)
The Reprocessed Compression Garments are intended to be used with an intermittent pneumatic device 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.
Compression Garments (Small and Medium Sizes)
The Reprocessed Compression Garments 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161105 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161105: Reprocessed Compression Garments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161105
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