510(k) · Cleared
ClearedModification to Resqpod 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 Nov 20, 2003 as substantially equivalent to K022906 (Cprx, LLC, 2003) after a 27-day review. Its family tree reaches back 1 generation to 2003. 3 later devices descend from it.
- Decided
- Nov 20, 2003
- Review
- 27 days
- Class
- Class II
- Product code
- BWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K022906 (2003). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK022906 Resqpod Circulatory EnhancerCprx, LLC · 2003
- This deviceK033401 Modification to Resqpod Circulatory EnhancerAdvanced Circulatory Systems, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK070490 Cirqlator Intrathoracic Pressure Regulator (Itpr)Advanced Circulatory Systems, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK172388 Vpod ItprAdvanced Circulatory System, A Wholly Owned Subsidiary OF · 2017
- Descendant · cites it directly · 0 of its ownK040084 Lifestyle Circulatory EnhancerAdvanced Circulatory Systems, Inc. · 2004
Most influential descendants
Showing 3 of 3 · See all- K070490Cirqlator Intrathoracic Pressure Regulator (Itpr)Advanced Circulatory Systems, Inc. · 2007 · cites it directly1descendant
- K172388Vpod ItprAdvanced Circulatory System, A Wholly Owned Subsidiary OF · 2017 · 2 generations on0descendants
- K040084Lifestyle Circulatory EnhancerAdvanced Circulatory Systems, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K022906 | Resqpod Circulatory Enhancer | Cprx, LLC | 2003 | — |
| 0 (this device) | K033401 | Modification to Resqpod Circulatory Enhancer | Advanced Circulatory Systems, Inc. | 2003 | — |
| +1 | K070490 | Cirqlator Intrathoracic Pressure Regulator (Itpr) | Advanced Circulatory Systems, Inc. | 2007 | — |
| +2 | K172388 | Vpod Itpr | Advanced Circulatory System, A Wholly Owned Subsidiary OF | 2017 | — |
| +1 | K040084 | Lifestyle Circulatory Enhancer | Advanced Circulatory Systems, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2017 | 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 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? (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 |
|---|---|---|---|
| * | K022906 | Resqpod Circulatory EnhancerSummary page 1…Enhancer (CE) device is mechanically and functionally equivalent to the unmodified, predicate ResQPOD CE reviewed and cleared for market in 5 loo<) K022906. This 5 lO(k) submission was provided to review the following feature additions: a) The addition of timi… | 2003 |
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?
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 ResQPOD Circulatory Enhancer is indicated for home, hospital, clinic and emergency care use, for the temporary increase in blood circulation as directed by a physician or licensed practitioner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033401 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033401: Modification to Resqpod Circulatory Enhancer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033401
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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