510(k) · Cleared
ClearedCirona DVT Foot Garment
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 Jul 1, 2013 as substantially equivalent to K964188 (Healthcare Service and Supply, 1997) and 1 other predicate after an 18-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Jul 1, 2013
- Review
- 18 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K991038 (2000). 6 ancestors in all, the oldest K961166 (1996). No later device cites it as a predicate yet.
- 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 deviceK131743 Cirona DVT Foot GarmentDevon Medical, Inc. · 2013
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) | K131743 | Cirona DVT Foot Garment | Devon Medical, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2002 | 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 |
|---|---|---|---|
| * | K964188 | Healthcare Service and Supply Pva (Pneumatic Venous Augmentation) Foot GarmentSummary page 1…m~eicate Devic:-,< K . Manufacturer>_ Sca kr~ HEALTHCARE SERVICE AND SUPPLY Healthcare Service and K964188 PVAIALP FOOT GARMENT Supply Devon Cirona 6100 DVT Prevention System Devon Medical, Inc… | 1997 |
| * | K130571 | Devon Cirona 6100 DVTSummary page 1…vice and K964188 PVAIALP FOOT GARMENT Supply Devon Cirona 6100 DVT Prevention System Devon Medical, Inc K1 30571 Device Description The Cirona TM deep vein thrombosis prevention therapy foot garment is intended to be used with Devon Cirona T… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 3.9 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 2 other devices also cite its predicate K964188.
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 DVT Prevention Therapy Foot Garment is a prescription device intended to
be used preventatively to increase venous.biood 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/K131743 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131743: Cirona DVT Foot Garment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131743
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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