510(k) · Cleared
ClearedBioarterial Plus, Arterial Blood Flow Enhancement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio Compression Systems, Inc. · JOW Sleeve, Limb, Compressible
Cleared on Nov 5, 2007 as substantially equivalent to K061857 (Bio Compression Systems, Inc., 2006) and 4 other predicates after a 45-day review. Its family tree reaches back 2 generations to 1988. 18 later devices descend from it.
- Decided
- Nov 5, 2007
- Review
- 45 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K881632 (1988). 9 ancestors in all. 18 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK881632 Flowtron DVT System AC500 Pump, L501 GarmentHuntleigh Technology, Inc. · 1988
- 1 generation backK061857 Model Multi-Flo IC-1545-KT/-F Intermittent CirculatorBio Compression Systems, Inc. · 2006
- This deviceK072666 Bioarterial Plus, Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc. · 2007
- Descendant · cites it directly · 14 of its ownK131327 Bioarterial Plus Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc. · 2013
- Descendant · 2 generations on · 12 of its ownK181149 Therm-X Pro, Therm-X AT, Therm-X Pro AthleteZenith Technical Innovations · 2018
- Descendant · 3 generations on · 11 of its ownK190854 Therm-XZenith Technical Innovations · 2019
- Descendant · 3 generations on · 10 of its ownK193550 Therm-XZenith Technical Innovations · 2020
- Descendant · 4 generations on · 3 of its ownK223729 FLOWpressoMedella Health Limited · 2023
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K131327Bioarterial Plus Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc. · 2013 · cites it directly14descendants
- K181149Therm-X Pro, Therm-X AT, Therm-X Pro AthleteZenith Technical Innovations · 2018 · 2 generations on12descendants
- K190854Therm-XZenith Technical Innovations · 2019 · 3 generations on11descendants
- K193550Therm-XZenith Technical Innovations · 2020 · 3 generations on10descendants
- K223729FLOWpressoMedella Health Limited · 2023 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K881632 | Flowtron DVT System AC500 Pump, L501 Garment | Huntleigh Technology, Inc. | 1988 | — |
| −1 | K061857 | Model Multi-Flo IC-1545-KT/-F Intermittent Circulator | Bio Compression Systems, Inc. | 2006 | — |
| 0 (this device) | K072666 | Bioarterial Plus, Arterial Blood Flow Enhancement System | Bio Compression Systems, Inc. | 2007 | — |
| +1 | K131327 | Bioarterial Plus Arterial Blood Flow Enhancement System | Bio Compression Systems, Inc. | 2013 | — |
| +2 | K181149 | Therm-X Pro, Therm-X AT, Therm-X Pro Athlete | Zenith Technical Innovations | 2018 | — |
| +3 | K190854 | Therm-X | Zenith Technical Innovations | 2019 | — |
| +3 | K193550 | Therm-X | Zenith Technical Innovations | 2020 | — |
| +4 | K223729 | FLOWpresso | Medella Health Limited | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 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? (5)
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 |
|---|---|---|---|
| * | K061857 | Model Multi-Flo IC-1545-KT/-F Intermittent CirculatorSummary page 2…mb Sleeve Devices are classified as Class IIdevices, and reviewed by the Division of Cardiovascular Devices. 6. PREDICATE DEVICE(s): K061 857 Model IC-1 545-KT/-F Intermittent Circulator * K942530 ACI Medical Art-Assist Model AA-1000 * K914461/K951683/K95… | 2006 |
| * | K942530 | Art-Assist Model AA-1000Summary page 2…d by the Division of Cardiovascular Devices. 6. PREDICATE DEVICE(s): K061 857 Model IC-1 545-KT/-F Intermittent Circulator * K942530 ACI Medical Art-Assist Model AA-1000 * K914461/K951683/K953648 Novamedix AV Impulse 7. DEVICE DESCRIPTION: The BioAr… | 1996 |
| * | K914461 | A-V Impulse SystemSummary page 2…6. PREDICATE DEVICE(s): K061 857 Model IC-1 545-KT/-F Intermittent Circulator * K942530 ACI Medical Art-Assist Model AA-1000 * K914461/K951683/K953648 Novamedix AV Impulse 7. DEVICE DESCRIPTION: The BioArterial Plus Arterial Blood Flow Enhancement System is i… | 1992 |
| * | K951683 | A-V Impulse System Model 6060Summary page 2…e 2 === 6. PREDICATE DEVICE(s): K061 857 Model IC-1 545-KT/-F Intermittent Circulator * K942530 ACI Medical Art-Assist Model AA-1000 * K914461/K951683/K953648 Novamedix AV Impulse 7. DEVICE DESCRIPTION: The BioArterial Plus Arterial Blood Flow Enhancement System is intended… | 1995 |
| * | K953648 | A-V Impulse System Model 6060Summary page 2…6. PREDICATE DEVICE(s): K061 857 Model IC-1 545-KT/-F Intermittent Circulator * K942530 ACI Medical Art-Assist Model AA-1000 * K914461/K951683/K953648 Novamedix AV Impulse 7. DEVICE DESCRIPTION: The BioArterial Plus Arterial Blood Flow Enhancement System is intended for the… | 1996 |
What descends from it? (18)
See all 184 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 19 years and passes through 2 companies; a new generation was cleared every 17.8 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K131327 (Bio Compression Systems, Inc., 2013) has gone furthest, with 14 descendants of its own.
- 1 other device also cites its predicate K061857.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 BioArterial Plus Arterial Blood Flow Enhancement System is intended as an adjunct therapy for patients with ischemic disease of the lower extremities, due to one or more of the following causes:
* Amputations (minor)
* Angioplasty / stent failure
* Arteriopathic wounds
* Graft failure
* Intermittent claudication
* Ischemia
* Night pain
* Rest pain
* Small vessel disease
* Ulcers
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072666 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072666: Bioarterial Plus, Arterial Blood Flow Enhancement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072666
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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