510(k) · Cleared
ClearedUniversity Health Care Processed Alternating Leg Pressure (Uhc Apl) Sleeve Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
University of Utah Hospitals and Clinics · JOW Sleeve, Limb, Compressible
Cleared on May 28, 2008 as substantially equivalent to K000303 (Healthcare Service and Supply, 2000) and 2 other predicates after a 90-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- May 28, 2008
- Review
- 90 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K012417 (2002). 12 ancestors in all, the oldest K890938 (1989). 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 deviceK080551 University Health Care Processed Alternating Leg Pressure (Uhc Apl)…University of Utah Hospitals and Clinics · 2008
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) | 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 |
|---|---|---|
| 1989 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 6 | 0 |
| 2003 | 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? (3)
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 |
|---|---|---|---|
| * | K000303 | Healthcare Service and Supply Alp Alternating Leg Pressure Pump and Garments for the LimbSummary page 1…Classification Name: Sleeve, Limb, Compression Predicate Device: Healthcare Service and Supply ALP® Alternating Leg Pressure Garment K000303 ReNu Medical Reprocessed ALP® Calf Garment KO051227 UUHC's Reprocessed Compression Slee… | 2000 |
| * | K051227 | Renu Medical Reprocessed Alp 1 Calf Garment, Model ALP1Summary page 1…vice: Healthcare Service and Supply ALP® Alternating Leg Pressure Garment K000303 ReNu Medical Reprocessed ALP® Calf Garment KO051227 UUHC's Reprocessed Compression Sleeve Device K03 1189 Device Description: U11C APL is the compression sleev… | 2006 |
| * | K031189 | Uuhc Reprocessed Compression Sleeve DevicesSummary page 1…nt K000303 ReNu Medical Reprocessed ALP® Calf Garment KO051227 UUHC's Reprocessed Compression Sleeve Device K03 1189 Device Description: U11C APL is the compression sleeve component of a non-invasive external compression syst… | 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 6 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- None of the 12 ancestors has a recall.
- 2 other devices also cite its predicate K000303.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 University Health Care Reprocessed Alternating Leg Pressure (UHC APL) sleeve device reprocessing methods do not change the intended use of the original manufacturer Healthcare Service and Supply ALP® (K000303) alternating leg pressure sleeve device. Both are sequential compression sleeves to be used by patients 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/K080551 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080551: University Health Care Processed Alternating Leg Pressure (Uhc Apl) Sleeve Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080551
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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