510(k) · Cleared
ClearedCircuflow 5150
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Devon Medical, Inc. · JOW Sleeve, Limb, Compressible
Cleared on Feb 28, 2013 as substantially equivalent to K101523 (Devon Medical, Inc., 2010) and 1 other predicate after a 69-day review. Its family tree reaches back 3 generations to 2005. 6 later devices descend from it.
- Decided
- Feb 28, 2013
- Review
- 69 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K043423 (2005). 4 ancestors in all. 6 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 deviceK123959 Circuflow 5150Devon Medical, Inc. · 2013
- Descendant · cites it directly · 4 of its ownK143185 entré Model PD08-UTactile Systems Technology, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK254217 AerloomEvolym, LLC · 2026
- Descendant · cites it directly · 0 of its ownK250817 Coretech Compression System (Coretech RHB3003)Vive Health, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK234155 Nimbl (model PD08-N1)Tactile Medical · 2024
- Descendant · 2 generations on · 0 of its ownK212287 Dayspring LiteKoya Medical, Inc. · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K143185entré Model PD08-UTactile Systems Technology, Inc. · 2015 · cites it directly4descendants
- K254217AerloomEvolym, LLC · 2026 · 2 generations on0descendants
- K250817Coretech Compression System (Coretech RHB3003)Vive Health, LLC · 2025 · cites it directly0descendants
- K234155Nimbl (model PD08-N1)Tactile Medical · 2024 · 2 generations on0descendants
- K212287Dayspring LiteKoya Medical, Inc. · 2021 · 2 generations on0descendants
View 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) | K123959 | Circuflow 5150 | Devon Medical, Inc. | 2013 | — |
| +1 | K143185 | entré Model PD08-U | Tactile Systems Technology, Inc. | 2015 | — |
| +2 | K254217 | Aerloom | Evolym, LLC | 2026 | — |
| +1 | K250817 | Coretech Compression System (Coretech RHB3003) | Vive Health, LLC | 2025 | — |
| +2 | K234155 | Nimbl (model PD08-N1) | Tactile Medical | 2024 | — |
| +2 | K212287 | Dayspring Lite | Koya Medical, Inc. | 2021 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K101523 | Circuflow 5200 Sequential Compression DeviceSummary page 1…Predicate Device I Manufacturer 510(k)# CircuFloTm 5200 Devon Medical, Inc. K1 01 523 CircuFlow Tm 5100 Devon Medical, Inc. K1 00446 Device Description The CircuFlowT… | 2010 |
| * | K100446 | Circuflow 5100 Sequential Compression DeviceSummary page 1…Tm 5200 Devon Medical, Inc. K1 01 523 CircuFlow Tm 5100 Devon Medical, Inc. K1 00446 Device Description The CircuFlowT m 5150 is a digitally controlled sequential pneumatic compression device designed to apply com… | 2010 |
What descends from it? (6)
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 8 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K143185 (Tactile Systems Technology, Inc., 2015) has gone furthest, with 4 descendants 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. 2013, 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 CircuFlowm 5150 Sequential Compression Device 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 both home and hospital use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123959 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123959: Circuflow 5150.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123959
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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