510(k) · Cleared
ClearedRenu Medical Vasopress Calf , Thigh Garments- All Sizesd, Renu Medical Vasopress Foot Garments
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 Jan 14, 2010 as substantially equivalent to K051227 (Renu Medical, Inc., 2006) after a 50-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Jan 14, 2010
- Review
- 50 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K012417 (2002). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK012417 Hygia Health Service Reprocessed Kendall SCD Sleeve, Models # 5329…Hygia Health Services, Inc. · 2002
- 2 generations backK031559 Renu Medical Reporcessed Compressible Limb SleevesRenu Medical, Inc. · 2003
- 1 generation backK051227 Renu Medical Reprocessed Alp 1 Calf Garment, Model ALP1Renu Medical, Inc. · 2006
- This deviceK093658 Renu Medical Vasopress Calf , Thigh Garments- All Sizesd, Renu…Renu Medical, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K012417 | Hygia Health Service Reprocessed Kendall SCD Sleeve, Models # 5329, 5330… | Hygia Health Services, Inc. | 2002 | — |
| −2 | K031559 | Renu Medical Reporcessed Compressible Limb Sleeves | Renu Medical, Inc. | 2003 | — |
| −1 | K051227 | Renu Medical Reprocessed Alp 1 Calf Garment, Model ALP1 | Renu Medical, Inc. | 2006 | — |
| 0 (this device) | K093658 | Renu Medical Vasopress Calf , Thigh Garments- All Sizesd, Renu Medical… | Renu Medical, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 6 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K051227 | Renu Medical Reprocessed Alp 1 Calf Garment, Model ALP1Summary page 1…mb, compression Product Code: JOW Panel: Cardiovascular 870.5800 Classification: Class 1I Equivalent Device(s) The ReNu Medical Reprocessed ALP DVT garments. 510k# K(051227 ReNu Medical Reprocessed many different manufacturers typestsizes DVT garments 510OW K031 159 De-vice Description: The ReNu Medi… | 2006 |
| Kept off the family tree | K031159 | FDA’s K031159 is Calibrating Material, Calibrating Standards Our reading of the summary gave K031159, FDA’s number for Calibrating Material, Calibrating Standards (Diamond Diagnostics, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “ReNu Medical Reprocessed many different manufacturers types/sizes…”. Kept off the family tree. Summary page 1…Equivalent Device(s) The ReNu Medical Reprocessed ALP DVT garments. 510k# K(051227 ReNu Medical Reprocessed many different manufacturers typestsizes DVT garments 510OW K031 159 De-vice Description: The ReNu Medical Reprocessed Vaso Press CTC calf, thigh and foot OWT garments. (All sizes) Indications for… | 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 8 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- None of the 9 ancestors has a recall.
- 1 other device also cites its predicate K051227.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Vaso Press CTC calf, thigh and foot DVT garments are to be used by patients in bath the home and institutional settings as a non-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/K093658 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093658: Renu Medical Vasopress Calf , Thigh Garments- All Sizesd, Renu Medical Vasopress Foot Garments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093658
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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