510(k) · Cleared
ClearedRenu Medical Reprocessed Alp 1 Calf Garment, Model ALP1
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 Apr 7, 2006 as substantially equivalent to K031559 (Renu Medical, Inc., 2003) after a 330-day review. Its family tree reaches back 2 generations to 2002. 2 later devices descend from it.
- Decided
- Apr 7, 2006
- Review
- 330 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K012417 (2002). 8 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK012417 Hygia Health Service Reprocessed Kendall SCD Sleeve, Models # 5329…Hygia Health Services, Inc. · 2002
- 1 generation backK031559 Renu Medical Reporcessed Compressible Limb SleevesRenu Medical, Inc. · 2003
- This deviceK051227 Renu Medical Reprocessed Alp 1 Calf Garment, Model ALP1Renu Medical, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK093658 Renu Medical Vasopress Calf , Thigh Garments- All Sizesd, Renu…Renu Medical, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK080551 University Health Care Processed Alternating Leg Pressure (Uhc Apl)…University of Utah Hospitals and Clinics · 2008
Most influential descendants
Showing 2 of 2 · See all- K093658Renu Medical Vasopress Calf , Thigh Garments- All Sizesd, Renu Medical Vasopress Foot…Renu Medical, Inc. · 2010 · cites it directly0descendants
- K080551University Health Care Processed Alternating Leg Pressure (Uhc Apl) Sleeve DeviceUniversity of Utah Hospitals and Clinics · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K012417 | Hygia Health Service Reprocessed Kendall SCD Sleeve, Models # 5329, 5330… | Hygia Health Services, Inc. | 2002 | — |
| −1 | K031559 | Renu Medical Reporcessed Compressible Limb Sleeves | Renu Medical, Inc. | 2003 | — |
| 0 (this device) | K051227 | Renu Medical Reprocessed Alp 1 Calf Garment, Model ALP1 | Renu Medical, Inc. | 2006 | — |
| +1 | K093658 | Renu Medical Vasopress Calf , Thigh Garments- All Sizesd, Renu Medical… | Renu Medical, Inc. | 2010 | — |
| +1 | K080551 | University Health Care Processed Alternating Leg Pressure (Uhc Apl) Sleeve… | University of Utah Hospitals and Clinics | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 6 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 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? (1)
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 |
|---|---|---|---|
| * | K031559 | Renu Medical Reporcessed Compressible Limb SleevesSummary page 1…Limb, Compression Product Code: JOW Panel Cardiovascular 870.5800 Classification: Class 1I Equivalent Device(s) Re Nu Medical Reprocessed Kendall Impad - 510(k) #K031559 Re Nu Medical Reprocessed Huntleigh Flowtron - 510(k) # 031559 Device Description: The ReNu Medical Reprocessed (up to 18" calf… | 2003 |
What descends from it? (2)
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 4 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K093658 (Renu Medical, Inc., 2010) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K031559.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 ALP®1 is to be used by patients in both the home and institutional settings as a non-invasive therapeutic method to:
* Prevent deep vein thrombosis and resulting pulmonary embolism.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051227 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051227: Renu Medical Reprocessed Alp 1 Calf Garment, Model ALP1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051227
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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