510(k) · Cleared
ClearedFlowtron ACS800 Pump and Tri Pulse Garments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arjohuntleigh Polska SP Z.O.O. · JOW Sleeve, Limb, Compressible
Cleared on Feb 28, 2014 as substantially equivalent to K010744 (Huntleigh Healthcare, Inc., 2002) and 1 other predicate after a 151-day review. Its family tree reaches back 2 generations to 1989. 2 later devices descend from it.
- Decided
- Feb 28, 2014
- Review
- 151 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K890938 (1989). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK890938 Kendall SCD Therapeutic SystemKendall Healthcare Products Co. Div.Of Tyco Health · 1989
- 1 generation backK012008 STS Range , Models STS20,STS30,STS40Huntleigh Healthcare, Inc. · 2001
- This deviceK133119 Flowtron ACS800 Pump and Tri Pulse GarmentsArjohuntleigh Polska SP Z.O.O. · 2014
- Descendant · cites it directly · 1 of its ownK143438 Flowtron ACS900Getinge (Suzhou) Co., Ltd. · 2015 · Recalled
- Descendant · 2 generations on · 0 of its ownK191937 Ezvena IPC, Ezvena SQSEezcare Medical Corp · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K890938 | Kendall SCD Therapeutic System | Kendall Healthcare Products Co. Div.Of Tyco Health | 1989 | — |
| −1 | K012008 | STS Range , Models STS20,STS30,STS40 | Huntleigh Healthcare, Inc. | 2001 | — |
| 0 (this device) | K133119 | Flowtron ACS800 Pump and Tri Pulse Garments | Arjohuntleigh Polska SP Z.O.O. | 2014 | — |
| +1 | K143438 | Flowtron ACS900 | Getinge (Suzhou) Co., Ltd. | 2015 | 1 |
| +2 | K191937 | Ezvena IPC, Ezvena SQS | Eezcare Medical Corp | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K010744 | Flowtron Universal, Model AC600Summary page 1…11I Jaw 870.5800 Classification Name: Sleeve, Limb, Compressible Predicate Devices: Flowtron Universal AC60O (K010744) cleared 26 Mar 2002, originally manufactured by Huntleigh Healthcare Ltd.… | 2002 |
| * | K012008 | STS Range , Models STS20,STS30,STS40Summary page 1…2, originally manufactured by Huntleigh Healthcare Ltd. and STS garments (K012008) cleared 21 Sept 2001 originally manufactured by Huntleigh Healthcare Ltd.… | 2001 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143438 | Flowtron ACS900 | 2015 | 1 |
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 25 years and passes through 3 companies; a new generation was cleared every 12.4 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K143438 (Getinge (Suzhou) Co., Ltd., 2015) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K010744.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
To help prevent Deep Vein Thrombosis (DVT)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133119 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133119: Flowtron ACS800 Pump and Tri Pulse Garments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133119
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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