510(k) · Cleared
ClearedIpc-Boot
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C-Boot, Ltd. · JOW Sleeve, Limb, Compressible
Cleared on May 3, 2007 as substantially equivalent to K041659 (C-Boot, Ltd., 2004) after an 87-day review. Its family tree reaches back 2 generations to 1981.
- Decided
- May 3, 2007
- Review
- 87 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K810338 (1981). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K810338 | Lympha Press | Mego Afek | 1981 | — |
| −1 | K041659 | C-BOOT | C-Boot, Ltd. | 2004 | — |
| 0 (this device) | K070324 | Ipc-Boot | C-Boot, Ltd. | 2007 | — |
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? (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 |
|---|---|---|---|
| * | K041659 | C-BOOTSummary page 2…Modified Device and change Description: C-Boot's IPC-Boot is actually a very similar version of C-Boot's legally marketed device, cleared under 5 10(k) number K041659. Similarly to the legally marketed device, it is made of the same materials and has the same design, techno… | 2004 |
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 26 years and passes through 2 companies; a new generation was cleared every 23.0 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K041659.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 IPC-Boot is a prescriptive device that induces controlled compression of the calf, the foot or a combined compression of both.
The IPC-Boot is intended to assist patients, suffering from lymphatic or venous disorders, by treating many conditions including:
1. Prevention of deep vein thrombosis (DVT)
2. Enhancement of blood circulation
3. Reduction of post-operative pain and swelling
4. Reduction of wound-healing time
5. Stasis dermatitis
6. Treatment and assist healing of cutaneous ulceration
7. Venous stasis ulcers
8. Leg ulcers
9. Chronic venous insufficiencies
10. Reduction of edema
11. Prevent pooling of fluids in limbs
12. Lymphedema
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070324 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070324: Ipc-Boot.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070324
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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