510(k) · Cleared
ClearedLifestyle Circulatory Enhancer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Circulatory Systems, Inc. · BWF Spirometer, Therapeutic (Incentive)
Cleared on Apr 7, 2004 as substantially equivalent to K022906 (Cprx, LLC, 2003) and 3 other predicates after an 83-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Apr 7, 2004
- Review
- 83 days
- Class
- Class II
- Product code
- BWF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K955138 (1995). 5 ancestors in all, the oldest K951234 (1995). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K955138 | Anti-EM/GP Stockings | Jobst Institute, Inc. | 1995 | — |
| −1 | K032325 | Jobst Travel Socks | Bsn-Jobst, Inc. | 2003 | — |
| 0 (this device) | K040084 | Lifestyle Circulatory Enhancer | Advanced Circulatory Systems, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2003 | 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 BWF? 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 BWF device
- #1 K241152 InSeescore 9.9 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K022906 | Resqpod Circulatory EnhancerSummary page 1…ing, Product Code: DWL Predicate Devices: 510(k) Manufacturer Product Code Class Trade Name K022906 Advanced Circulatory BWF, JOW II ResQPOD TM Circulatory Systems, Inc… | 2003 |
| * | K033401 | Modification to Resqpod Circulatory EnhancerSummary page 1…BWF, JOW II ResQPOD TM Circulatory Systems, Inc. Enhancer K033401 Advanced Circulatory BWF, JOW I Modification of the Systems, Inc.… | 2003 |
| * | K032325 | Jobst Travel SocksSummary page 1…ResQPOD T M Circulatory Enhancer K032325, Jobst A Beiersdorf Co. DWL I Medical Support Stockings K951234… | 2003 |
| * | K951234 | Medical Support StockingsSummary page 1…Enhancer K032325, Jobst A Beiersdorf Co. DWL I Medical Support Stockings K951234 and other comumercial names 1.0 Description of Device Th… | 1995 |
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 9 years and passes through 3 companies; a new generation was cleared every 7.7 years on median.
- None of the 5 ancestors has a recall.
- 2 other devices also cite its predicate K022906.
How does its category compare?
All BWF devicesBWF Spirometer, Therapeutic (Incentive): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BWF
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BWF
281in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BWF
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BWF
3in 2025
MAUDE reports naming product code BWF, 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 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 2 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 39 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 1 | — | 0 | 19 |
| 2014 | 3 | 105 | 0 | 5 |
| 2015 | 1 | — | 0 | 16 |
| 2016 | 3 | 149 | 0 | 6 |
| 2017 | 3 | 136 | 0 | 7 |
| 2018 | 1 | — | 0 | 7 |
| 2019 | 3 | 281 | 0 | 16 |
| 2020 | 1 | — | 1 | 5 |
| 2021 | 1 | — | 0 | 9 |
| 2022 | 1 | — | 0 | 8 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 11 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Lifestyle Circulatory Enhancer (CE) is indicated for the temporary increase in blood circulation as prescribed by a physician or licensed practitioner. The Lifestyle CE may benefit people who suffer from states of poor circulation and low blood flow, including those individuals who suffer from orthostatic hypotension symptoms, such as lightheadedness, when moving from a sitting or reclining position to a standing position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040084 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040084: Lifestyle Circulatory Enhancer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040084
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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