510(k) · Cleared
ClearedSTS Range , Models STS20,STS30,STS40
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Huntleigh Healthcare, Inc. · JOW Sleeve, Limb, Compressible
Cleared on Sep 21, 2001 as substantially equivalent to K890938 (Kendall Healthcare Products Co. Div.Of Tyco Health, 1989) after an 86-day review. Its family tree reaches back 1 generation to 1989. 3 later devices descend from it.
- Decided
- Sep 21, 2001
- Review
- 86 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K890938 (1989). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK890938 Kendall SCD Therapeutic SystemKendall Healthcare Products Co. Div.Of Tyco Health · 1989
- This deviceK012008 STS Range , Models STS20,STS30,STS40Huntleigh Healthcare, Inc. · 2001
- Descendant · cites it directly · 2 of its ownK133119 Flowtron ACS800 Pump and Tri Pulse GarmentsArjohuntleigh Polska SP Z.O.O. · 2014
- Descendant · 2 generations on · 1 of its ownK143438 Flowtron ACS900Getinge (Suzhou) Co., Ltd. · 2015 · Recalled
- Descendant · 3 generations on · 0 of its ownK191937 Ezvena IPC, Ezvena SQSEezcare Medical Corp · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K890938 | Kendall SCD Therapeutic System | Kendall Healthcare Products Co. Div.Of Tyco Health | 1989 | — |
| 0 (this device) | K012008 | STS Range , Models STS20,STS30,STS40 | Huntleigh Healthcare, Inc. | 2001 | — |
| +1 | K133119 | Flowtron ACS800 Pump and Tri Pulse Garments | Arjohuntleigh Polska SP Z.O.O. | 2014 | — |
| +2 | K143438 | Flowtron ACS900 | Getinge (Suzhou) Co., Ltd. | 2015 | 1 |
| +3 | K191937 | Ezvena IPC, Ezvena SQS | Eezcare Medical Corp | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K890938 | Kendall SCD Therapeutic SystemSummary page 1…gth Large Size Common Name Gradient, Sequential Compression Sleeves Classification Name Sleeve, Limb, Compression (JOW) Predicate Device Kendall SCD Therapeutic System K890938 Device Description The STS range of sleeves, are three chamber graduated, sequential compression sleeves, to be used in conjunct… | 1989 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133119 | Flowtron ACS800 Pump and Tri Pulse Garments | 2014 | 2 |
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 STS system is designed to help prevent Deep Vein Thrombosis (DVT), by increasing venous blood flow.
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/K012008 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012008: STS Range , Models STS20,STS30,STS40.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012008
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026