510(k) · Cleared
ClearedCurrie Medical Reprocessed Alp Calf/Thigh/Foot Compression Sleeve (All Sizes)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Currie Medical Specialties, Inc. · JOW Sleeve, Limb, Compressible
Cleared on Apr 16, 2014 as substantially equivalent to K955853 (Healthcare Service and Supply, 1996) and 1 other predicate after a 92-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Apr 16, 2014
- Review
- 92 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K955853 (1996). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK955853 Healthcare Service & Supply Pump Alp 501 Pump SystemHealthcare Service and Supply · 1996
- This deviceK140092 Currie Medical Reprocessed Alp Calf/Thigh/Foot Compression Sleeve…Currie Medical Specialties, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955853 | Healthcare Service & Supply Pump Alp 501 Pump System | Healthcare Service and Supply | 1996 | — |
| 0 (this device) | K140092 | Currie Medical Reprocessed Alp Calf/Thigh/Foot Compression Sleeve (All Sizes) | Currie Medical Specialties, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 |
|---|---|---|---|
| * | K955853 | Healthcare Service & Supply Pump Alp 501 Pump SystemSummary page 1…ardiovascular Regulation Number: 870.5800 Classification: Class 11 Predicate Device(s):. K955853 - Healthcare Service & Supply Pump ALP 501 System K(964188 - Healthcare Service & Su… | 1996 |
| * | K964188 | Healthcare Service and Supply Pva (Pneumatic Venous Augmentation) Foot GarmentSummary page 2…ocessing did not compromise the performance or safety and efficacy of the device in a manner that is substantially equivalent to that of the predicate devices (K955853 & K964188). Bench testing was conducted to demonstrate a bladder leak test where the bladders were pressurized to 3 psi to ensure the blad… | 1997 |
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?
- None of the 2 ancestors has a recall.
- 3 other devices also cite its predicate K955853.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Currie Medical Reprocessed ALP* Calf, Thigh and Foot Compression Sleeves (all sizes) are recommended for the use in patients for whom external compression therapy using the ALTERNATING LEG PRESSUREO (ALPO) SYSTEM is indicated to reduce the incidence of deep vein thrombosis and resulting pulmonary embolism due to the presence of risk factors for thrombosis formation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140092 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140092: Currie Medical Reprocessed Alp Calf/Thigh/Foot Compression Sleeve (All Sizes).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140092
Report an extraction error
Are you the manufacturer?
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