510(k) · Cleared
ClearedComfysleeve 1-75 and Lymphapod Sleeves, for Use with LP Optimal and Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mego Afek AC, Ltd. · JOW Sleeve, Limb, Compressible
Cleared on May 14, 2010 as substantially equivalent to K082149 (Mego Afek AC, Ltd., 2008) and 1 other predicate after an 80-day review. Its family tree reaches back 3 generations to 1981.
- Decided
- May 14, 2010
- Review
- 80 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K810338 (1981). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK810338 Lympha PressMego Afek · 1981
- 2 generations backK013331 Lympha Press Plus DeviceMego Afek · 2001
- 1 generation backK082149 Lympha Press Optimal, Model# 1201APMego Afek AC, Ltd. · 2008
- This deviceK100521 Comfysleeve 1-75 and Lymphapod Sleeves, for Use with LP Optimal and…Mego Afek AC, Ltd. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K810338 | Lympha Press | Mego Afek | 1981 | — |
| −2 | K013331 | Lympha Press Plus Device | Mego Afek | 2001 | — |
| −1 | K082149 | Lympha Press Optimal, Model# 1201AP | Mego Afek AC, Ltd. | 2008 | — |
| 0 (this device) | K100521 | Comfysleeve 1-75 and Lymphapod Sleeves, for Use with LP Optimal and Plus | Mego Afek AC, Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 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.
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 29 years and passes through 2 companies; a new generation was cleared every 6.9 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K082149.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
Primary lymphederna (for example congenital! milroy's disease)
Secondary lymphedemna (for example post-mastectomy, chronic edema, post-traumatic edema)
Venous disorders (for example venous insufficiency, varicose veins, venous stasis ulcers)
Dysfunction of the muscle pump (for example promotion of wound recovery, reduction of edema and lower limb pain following trauma and-sports injuries.)
The garments are intended to be used by the patient at home, as well as by physicians at clinics or hospitals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100521 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100521: Comfysleeve 1-75 and Lymphapod Sleeves, for Use with LP Optimal and Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100521
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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