510(k) · Cleared
ClearedDevon Cirona 6200 DVT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Devon Medical · JOW Sleeve, Limb, Compressible
Cleared on Jun 27, 2014 as substantially equivalent to K130571 (Devon Medical, Inc., 2013) and 2 other predicates after a 14-day review. Its family tree reaches back 3 generations to 2000. 4 later devices descend from it.
- Decided
- Jun 27, 2014
- Review
- 14 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K991038 (2000). 5 ancestors in all, the oldest K961166 (1996). 4 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK991038 Vaso Press DVT System, Models VP500, VP501Britt Corp., Inc. · 2000
- 2 generations backK090308 Restep Dvy System, Model RSP-101Stortford Medical, LLC · 2009 · Recalled
- 1 generation backK130571 Devon Cirona 6100 DVTDevon Medical, Inc. · 2013
- This deviceK141578 Devon Cirona 6200 DVTDevon Medical · 2014
- Descendant · cites it directly · 0 of its ownK241096 Venera 608 Deep Vein Thrombosis (DVT) Prevention SystemSuzhou Minhua Medical Apparatus Supplies Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK211253 PlasmaWaveManamed, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK190975 Plexus SCD110 Sequential Compression Device SleeveMidway Medical, LLC · 2019
- Descendant · cites it directly · 0 of its ownK182578 Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy DeviceDevon Medical Products (Jiangsu), Ltd. · 2019
Most influential descendants
Showing 4 of 4 · See all- K241096Venera 608 Deep Vein Thrombosis (DVT) Prevention SystemSuzhou Minhua Medical Apparatus Supplies Co., Ltd. · 2025 · cites it directly0descendants
- K211253PlasmaWaveManamed, Inc. · 2021 · cites it directly0descendants
- K190975Plexus SCD110 Sequential Compression Device SleeveMidway Medical, LLC · 2019 · cites it directly0descendants
- K182578Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy DeviceDevon Medical Products (Jiangsu), Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K991038 | Vaso Press DVT System, Models VP500, VP501 | Britt Corp., Inc. | 2000 | — |
| −2 | K090308 | Restep Dvy System, Model RSP-101 | Stortford Medical, LLC | 2009 | 1 |
| −1 | K130571 | Devon Cirona 6100 DVT | Devon Medical, Inc. | 2013 | — |
| 0 (this device) | K141578 | Devon Cirona 6200 DVT | Devon Medical | 2014 | — |
| +1 | K241096 | Venera 608 Deep Vein Thrombosis (DVT) Prevention System | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | 2025 | — |
| +1 | K211253 | PlasmaWave | Manamed, Inc. | 2021 | — |
| +1 | K190975 | Plexus SCD110 Sequential Compression Device Sleeve | Midway Medical, LLC | 2019 | — |
| +1 | K182578 | Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device | Devon Medical Products (Jiangsu), Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2021 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K130571 | Devon Cirona 6100 DVTSummary page 1…Aoiicatfe.Deyice, .j~ianufactu rr; 1~ 1~)Y~ Cirona 6100 Devon Medical Products K130571 RESTEP DVT SYSTEM, MODEL STORTFORD MEDICAL K090308 RSP-101… | 2013 |
| * | K090308 | Restep Dvy System, Model RSP-101Summary page 1…~ Cirona 6100 Devon Medical Products K130571 RESTEP DVT SYSTEM, MODEL STORTFORD MEDICAL K090308 RSP-101 LLC Flowtroni Universal AC600 HNE HEALTHCARE, I… | 2009 |
| * | K010744 | Flowtron Universal, Model AC600Summary page 1…ORTFORD MEDICAL K090308 RSP-101 LLC Flowtroni Universal AC600 HNE HEALTHCARE, INC K010744 Device Description The Cirona TM 6200 Series deep vein thrombosis prevention system is a pneumatic compression device that nonin… | 2002 |
What descends from it? (4)
4 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?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K241096 (Suzhou Minhua Medical Apparatus Supplies Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K130571.
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?
The Cirona 6200 Series system is a prescription device intended to be used preventatively to increase venous blood flaw
in patients at risk of deep vein thrombosis due to the associated risk factors for thrombus formation during: trauma,
critical care, general medicine, general surgery, as well as neurological, orthopedic, urologic, obstetric conditions and
treatments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141578 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141578: Devon Cirona 6200 DVT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141578
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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