510(k) · Cleared
ClearedFlowtron Excel Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hne Healthcare, Inc. · JOW Sleeve, Limb, Compressible
Cleared on Oct 11, 1996 after a 200-day review. The FDA summary names its predicate without a number. 42 later devices descend from it.
- Decided
- Oct 11, 1996
- Review
- 200 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 0
42 later devices descend from it, 4 citing it directly.
- This deviceK961166 Flowtron Excel PumpHne Healthcare, Inc. · 1996
- Descendant · cites it directly · 30 of its ownK061125 Dvtcare CA5Doctors Orders · 2006
- Descendant · 2 generations on · 25 of its ownK103187 Tripleplay-VT Vascular Therapy SystemWildcat Medical, Inc. · 2011
- Descendant · 2 generations on · 22 of its ownK133274 Vena ProInnovamed Health, LLC · 2014
- Descendant · cites it directly · 6 of its ownK130571 Devon Cirona 6100 DVTDevon Medical, Inc. · 2013
- Descendant · 3 generations on · 5 of its ownK151189 Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention SystemDevon Medical Products · 2015
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 42 · See all- K061125Dvtcare CA5Doctors Orders · 2006 · cites it directly30descendants
- K103187Tripleplay-VT Vascular Therapy SystemWildcat Medical, Inc. · 2011 · 2 generations on25descendants
- K133274Vena ProInnovamed Health, LLC · 2014 · 2 generations on22descendants
- K130571Devon Cirona 6100 DVTDevon Medical, Inc. · 2013 · cites it directly6descendants
- K151189Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention SystemDevon Medical Products · 2015 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961166 | Flowtron Excel Pump | Hne Healthcare, Inc. | 1996 | — |
| +1 | K061125 | Dvtcare CA5 | Doctors Orders | 2006 | — |
| +2 | K103187 | Tripleplay-VT Vascular Therapy System | Wildcat Medical, Inc. | 2011 | — |
| +2 | K133274 | Vena Pro | Innovamed Health, LLC | 2014 | — |
| +1 | K130571 | Devon Cirona 6100 DVT | Devon Medical, Inc. | 2013 | — |
| +3 | K151189 | Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System | Devon Medical Products | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 5 | 0 |
| 2020 | 3 | 0 |
| 2021 | 6 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | — | Flowtron®DVT Named without a submission number | |
| * | — | AC500 Named without a submission number |
What descends from it? (42)
See all 424 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K061125 (Doctors Orders, 2006) has gone furthest, with 30 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 | — |
What is it indicated for?
The AC550 Flowtron®Excel pump, coupled with the Flowtron DVT compression garments, is an external pneumatic compression system used to prevent deep vein thrombosis (DVT) in patients deemed to be at risk by their physicians.
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/K961166 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961166: Flowtron Excel Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961166
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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