510(k) · Cleared
ClearedDevon Cirona 6100 DVT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Devon Medical, Inc. · JOW Sleeve, Limb, Compressible
Cleared on Apr 9, 2013 as substantially equivalent to K961166 (Hne Healthcare, Inc., 1996) and 3 other predicates after a 36-day review. Its family tree reaches back 2 generations to 2000. 6 later devices descend from it.
- Decided
- Apr 9, 2013
- Review
- 36 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K991038 (2000). 4 ancestors in all, the oldest K961166 (1996). 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK991038 Vaso Press DVT System, Models VP500, VP501Britt Corp., Inc. · 2000
- 1 generation backK090308 Restep Dvy System, Model RSP-101Stortford Medical, LLC · 2009 · Recalled
- This deviceK130571 Devon Cirona 6100 DVTDevon Medical, Inc. · 2013
- Descendant · cites it directly · 4 of its ownK141578 Devon Cirona 6200 DVTDevon Medical · 2014
- Descendant · 2 generations on · 0 of its ownK241096 Venera 608 Deep Vein Thrombosis (DVT) Prevention SystemSuzhou Minhua Medical Apparatus Supplies Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK211253 PlasmaWaveManamed, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK190975 Plexus SCD110 Sequential Compression Device SleeveMidway Medical, LLC · 2019
- Descendant · 2 generations on · 0 of its ownK182578 Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy DeviceDevon Medical Products (Jiangsu), Ltd. · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K141578Devon Cirona 6200 DVTDevon Medical · 2014 · cites it directly4descendants
- K241096Venera 608 Deep Vein Thrombosis (DVT) Prevention SystemSuzhou Minhua Medical Apparatus Supplies Co., Ltd. · 2025 · 2 generations on0descendants
- K211253PlasmaWaveManamed, Inc. · 2021 · 2 generations on0descendants
- K190975Plexus SCD110 Sequential Compression Device SleeveMidway Medical, LLC · 2019 · 2 generations on0descendants
- K182578Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy DeviceDevon Medical Products (Jiangsu), Ltd. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K991038 | Vaso Press DVT System, Models VP500, VP501 | Britt Corp., Inc. | 2000 | — |
| −1 | K090308 | Restep Dvy System, Model RSP-101 | Stortford Medical, LLC | 2009 | 1 |
| 0 (this device) | K130571 | Devon Cirona 6100 DVT | Devon Medical, Inc. | 2013 | — |
| +1 | K141578 | Devon Cirona 6200 DVT | Devon Medical | 2014 | — |
| +2 | K241096 | Venera 608 Deep Vein Thrombosis (DVT) Prevention System | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | 2025 | — |
| +2 | K211253 | PlasmaWave | Manamed, Inc. | 2021 | — |
| +2 | K190975 | Plexus SCD110 Sequential Compression Device Sleeve | Midway Medical, LLC | 2019 | — |
| +2 | 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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | K961166 | Flowtron Excel PumpSummary page 1…Device Manufacturer . 1~) Flowtron Excel AC5O0 HNE HEALTHCARE, INC K961166 VASO PRESS DVT SYSTEM, MODELS VP500, VP501 BRITT CORP., INC K991038 RESTEP DVT SYSTEM, MOD… | 1996 |
| * | K991038 | Vaso Press DVT System, Models VP500, VP501Summary page 1…HNE HEALTHCARE, INC K961166 VASO PRESS DVT SYSTEM, MODELS VP500, VP501 BRITT CORP., INC K991038 RESTEP DVT SYSTEM, MODEL RSP-101 STORTFORD MEDICAL LLC K(090308 Flowtron Universal AC… | 2000 |
| * | K090308 | Restep Dvy System, Model RSP-101Summary page 1…ELS VP500, VP501 BRITT CORP., INC K991038 RESTEP DVT SYSTEM, MODEL RSP-101 STORTFORD MEDICAL LLC K(090308 Flowtron Universal AC600 HNE HEALTHCARE, INC K010744 Device Description The C… | 2009 |
| * | K010744 | Flowtron Universal, Model AC600Summary page 1…RSP-101 STORTFORD MEDICAL LLC K(090308 Flowtron Universal AC600 HNE HEALTHCARE, INC K010744 Device Description The Cirona Tm6100 deep vein thrombosis prevention system is a pneumatic compression device that noninvasivel… | 2002 |
What descends from it? (6)
2 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 13 years and passes through 3 companies; a new generation was cleared every 8.9 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K141578 (Devon Medical, 2014) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K961166.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 TM 6100 system is a prescription device intended to be used preventatively to
increase venous blood flow 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/K130571 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130571: Devon Cirona 6100 DVT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130571
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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