510(k) · Cleared
Clearedmedi pneumatic compression system (pcs) – brio (Model 651)
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 Jan 25, 2019 as substantially equivalent to K101523 (Devon Medical, Inc., 2010) after a 30-day review. Its family tree reaches back 3 generations to 2005. 3 later devices descend from it.
- Decided
- Jan 25, 2019
- Review
- 30 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K043423 (2005). 4 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK043423 Model SC-3008 Sequential CirculatorBio Compression Systems, Inc. · 2005
- 2 generations backK100446 Circuflow 5100 Sequential Compression DeviceDevon Medical, Inc. · 2010
- 1 generation backK101523 Circuflow 5200 Sequential Compression DeviceDevon Medical, Inc. · 2010
- This deviceK183631 medi pneumatic compression system (pcs) – brio (Model 651)Medi USA, LP · 2019
- Descendant · cites it directly · 1 of its ownK200353 ManaFlowManamed, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK240011 Lymphedema CompressionJkh Health Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK221654 medi pneumatic compression system (pcs)-genius (Model 652)Medi USA, LP · 2022
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K043423 | Model SC-3008 Sequential Circulator | Bio Compression Systems, Inc. | 2005 | — |
| −2 | K100446 | Circuflow 5100 Sequential Compression Device | Devon Medical, Inc. | 2010 | — |
| −1 | K101523 | Circuflow 5200 Sequential Compression Device | Devon Medical, Inc. | 2010 | — |
| 0 (this device) | K183631 | medi pneumatic compression system (pcs) – brio (Model 651) | Medi USA, LP | 2019 | — |
| +1 | K200353 | ManaFlow | Manamed, Inc. | 2020 | — |
| +2 | K240011 | Lymphedema Compression | Jkh Health Co., Ltd. | 2024 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K101523 | Circuflow 5200 Sequential Compression DeviceSummary page 4…ssible Limb Sleeve (21 CFR 870.5800) Regulatory Class: II, Product Code: JOW III. PREDICATE DEVICES Primary- CircuFlow 5200 Series Sequential Compression Device (K101523) The predicate device has not been subject to a design-related recall IV. DEVICE DESCRIPTION The medi pneumatic compres… | 2010 |
What descends from it? (3)
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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K200353 (Manamed, Inc., 2020) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K101523.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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) – brio 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/K183631 · printed Nov 5, 2026
Cite this page
510(k) Report. “K183631: medi pneumatic compression system (pcs) – brio (Model 651).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K183631
Report an extraction error
Are you the manufacturer?
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