510(k) · Cleared
ClearedAerloom
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Evolym, LLC · JOW Sleeve, Limb, Compressible
Cleared on Aug 31, 2026 as substantially equivalent to K143185 (Tactile Systems Technology, Inc., 2015) after a 245-day review. Its family tree reaches back 6 generations to 1981.
- Decided
- Aug 31, 2026
- Review
- 245 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K810338 (1981). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK810338 Lympha PressMego Afek · 1981
- 5 generations backK013331 Lympha Press Plus DeviceMego Afek · 2001
- 4 generations backK082149 Lympha Press Optimal, Model# 1201APMego Afek AC, Ltd. · 2008
- 3 generations backK100677 Lympha Press 201MAX, Model 201MAXMego Afek AC, Ltd. · 2010
- 2 generations backK123647 Circuflow 5208 Sequential Compression DeviceDevon Medical, Inc. · 2013
- 1 generation backK143185 entré Model PD08-UTactile Systems Technology, Inc. · 2015
- This deviceK254217 AerloomEvolym, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K810338 | Lympha Press | Mego Afek | 1981 | — |
| −5 | K013331 | Lympha Press Plus Device | Mego Afek | 2001 | — |
| −4 | K082149 | Lympha Press Optimal, Model# 1201AP | Mego Afek AC, Ltd. | 2008 | — |
| −3 | K100677 | Lympha Press 201MAX, Model 201MAX | Mego Afek AC, Ltd. | 2010 | — |
| −2 | K123647 | Circuflow 5208 Sequential Compression Device | Devon Medical, Inc. | 2013 | — |
| −1 | K143185 | entré Model PD08-U | Tactile Systems Technology, Inc. | 2015 | — |
| 0 (this device) | K254217 | Aerloom | Evolym, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 2 | 0 |
| 2010 | 2 | 0 |
| 2013 | 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? (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 |
|---|---|---|---|
| * | K143185 | entré Model PD08-USummary page 5…JOW III. PREDICATE DEVICE: Manufacturer: Tactile Systems Technology Inc. Trade Name: entré, Model PD08-U 510(k): K143185 510(k) Summary Page 1 === Page 6… | 2015 |
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 45 years and passes through 5 companies; a new generation was cleared every 6.9 years on median.
- None of the 14 ancestors has a recall.
- 3 other devices also cite its predicate K143185.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Aerloom system is intended for use by medical professionals and patients who are under medical supervision, for the treatment of the following conditions:
Chronic edema
Lymphedema
Venous insufficiency
Wound healing
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K254217 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254217: Aerloom.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254217
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026