510(k) · Cleared
ClearedRenu Medical Reprocessed Aircast Venaflow Calf Garments/All Sizes, Renu Medical Reprocessed Aircast Venaflow Thigh Garme
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Renu Medical, Inc. · JOW Sleeve, Limb, Compressible
Cleared on Jun 12, 2012 as substantially equivalent to K992454 (Aircast, Inc., 2000) and 1 other predicate after a 57-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- Jun 12, 2012
- Review
- 57 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. No later device cites it as a predicate yet.
- Root · 2 generations backK890938 Kendall SCD Therapeutic SystemKendall Healthcare Products Co. Div.Of Tyco Health · 1989
- 1 generation backK031189 Uuhc Reprocessed Compression Sleeve DevicesUniversity of Utah Hospitals and Clinics · 2003
- This deviceK121145 Renu Medical Reprocessed Aircast Venaflow Calf Garments/All Sizes…Renu Medical, Inc. · 2012
View 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 | K031189 | Uuhc Reprocessed Compression Sleeve Devices | University of Utah Hospitals and Clinics | 2003 | — |
| 0 (this device) | K121145 | Renu Medical Reprocessed Aircast Venaflow Calf Garments/All Sizes, Renu… | Renu Medical, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 |
|---|---|---|---|
| * | K992454 | Venaflow System, Model 30ASummary page 1…T garments. (All Sizes) Common Name: Sleeve, limb, compression Product Code: JOW Panel: Cardiovascular 870.5800 Classification: Class 11 Equivalent Device(s) 510k# K992454, Venalow System 30A Aircast Venalow DVT garments. (All Sizes). 510k# K0311S9 ReNu Medical Reprocessed Compression Sleeves differe… | 2000 |
| * | K031189 | Uuhc Reprocessed Compression Sleeve Devices Our reading of the summary gave K031159, FDA’s number for Calibrating Material, Calibrating Standards (Diamond Diagnostics, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “ReNu Medical Reprocessed Compression Sleeves different manufactures…”. | 2003 |
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 23 years and passes through 3 companies; a new generation was cleared every 14.4 years on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K992454.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 ReNu Medical Reprocessed Aircast Venalow calf, thigh and foot DVT garments are to be used by patients in both the home and institutional settings as a nan-invasive therapeutic method to prevent deep vien thrombosis and resulting pulmonary embolism.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121145 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121145: Renu Medical Reprocessed Aircast Venaflow Calf Garments/All Sizes, Renu Medical Reprocessed Aircast Venaflow Thigh Garme.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121145
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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