510(k) · Cleared
Clearedmedi pneumatic compression system (pcs)-genius (Model 652)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medi USA, LP · JOW Sleeve, Limb, Compressible
Cleared on Jul 7, 2022 as substantially equivalent to K183631 (Medi USA, LP, 2019) after a 30-day review. Its family tree reaches back 4 generations to 2005.
- Decided
- Jul 7, 2022
- Review
- 30 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K043423 (2005). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK043423 Model SC-3008 Sequential CirculatorBio Compression Systems, Inc. · 2005
- 3 generations backK100446 Circuflow 5100 Sequential Compression DeviceDevon Medical, Inc. · 2010
- 2 generations backK101523 Circuflow 5200 Sequential Compression DeviceDevon Medical, Inc. · 2010
- 1 generation backK183631 medi pneumatic compression system (pcs) – brio (Model 651)Medi USA, LP · 2019
- This deviceK221654 medi pneumatic compression system (pcs)-genius (Model 652)Medi USA, LP · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K043423 | Model SC-3008 Sequential Circulator | Bio Compression Systems, Inc. | 2005 | — |
| −3 | K100446 | Circuflow 5100 Sequential Compression Device | Devon Medical, Inc. | 2010 | — |
| −2 | K101523 | Circuflow 5200 Sequential Compression Device | Devon Medical, Inc. | 2010 | — |
| −1 | K183631 | medi pneumatic compression system (pcs) – brio (Model 651) | Medi USA, LP | 2019 | — |
| 0 (this device) | K221654 | medi pneumatic compression system (pcs)-genius (Model 652) | Medi USA, LP | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 |
|---|---|---|---|
| * | K183631 | medi pneumatic compression system (pcs) – brio (Model 651)Summary page 4…Sleeve (21 CFR 870.5800) Regulatory Class: II Product Code: JOW III. PREDICATE DEVICE Name of Device: medi pneumatic compression system (pcs) – brio (Model 651) (K183631) Common or Usual Name: Compressible Limb Sleeve Classification Name: Compressible Limb Sleeve (21 CFR 870.5800) Regulator… | 2019 |
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 17 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K183631.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 medi pneumatic compression system (pcs) genius is a compression device based on sequential pneumatic compression technique which is intended for the treatment of the following conditions:
-Lymphedema
-Venous stasis ulcers
-Venous insufficiency
-Peripheral edema
The device is intended for home, and hospital use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221654 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221654: medi pneumatic compression system (pcs)-genius (Model 652).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221654
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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