510(k) · Cleared
ClearedC-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 Oct 28, 2004 as substantially equivalent to K002287 (Medical Compression Systems (Dbn), Ltd., 2000) and 1 other predicate after a 132-day review. Its family tree reaches back 1 generation to 1981. 2 later devices descend from it.
- Decided
- Oct 28, 2004
- Review
- 132 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K810338 (1981). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK810338 Lympha PressMego Afek · 1981
- This deviceK041659 C-BOOTC-Boot, Ltd. · 2004
- Descendant · cites it directly · 0 of its ownK070457 Sun Scientific LLC-Leg Compressor and PfabSun Scientific, LLC · 2007
- Descendant · cites it directly · 0 of its ownK070324 Ipc-BootC-Boot, Ltd. · 2007
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K810338 | Lympha Press | Mego Afek | 1981 | — |
| 0 (this device) | K041659 | C-BOOT | C-Boot, Ltd. | 2004 | — |
| +1 | K070457 | Sun Scientific LLC-Leg Compressor and Pfab | Sun Scientific, LLC | 2007 | — |
| +1 | K070324 | Ipc-Boot | C-Boot, Ltd. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 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 |
|---|---|---|---|
| * | K002287 | Wizair Compression SystemSummary page 2…"WizAir" T Ambulant Pneumatic Compression System" (of MCS), 510(k) number K002287 cleared on 25-Aug- 2000; It is also substantially equivalent to the commercially… | 2000 |
| * | K810338 | Lympha PressSummary page 2…It is also substantially equivalent to the commercially available Lympha Press® (of Mego-Afek), 510(k) number K810338 cleared on 20-Oct-1981. 8. Device Description C-BootLtd. introduces a wearable pne… | 1981 |
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?
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 C-Boot T M is a prescriptive device that induces controlled compression of the calf, the foot or a combined compression of both.
The C-Boot T M 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/K041659 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041659: C-BOOT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041659
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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