510(k) · Cleared
ClearedVpod Itpr
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Circulatory System, A Wholly Owned Subsidiary OF · BWF Spirometer, Therapeutic (Incentive)
Cleared on Dec 22, 2017 as substantially equivalent to K070490 (Advanced Circulatory Systems, Inc., 2007) after a 136-day review. Its family tree reaches back 3 generations to 2003.
- Decided
- Dec 22, 2017
- Review
- 136 days
- Class
- Class II
- Product code
- BWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K022906 (2003). No later device cites it as a predicate yet.
- Root · 3 generations backK022906 Resqpod Circulatory EnhancerCprx, LLC · 2003
- 2 generations backK033401 Modification to Resqpod Circulatory EnhancerAdvanced Circulatory Systems, Inc. · 2003
- 1 generation backK070490 Cirqlator Intrathoracic Pressure Regulator (Itpr)Advanced Circulatory Systems, Inc. · 2007
- This deviceK172388 Vpod ItprAdvanced Circulatory System, A Wholly Owned Subsidiary OF · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K022906 | Resqpod Circulatory Enhancer | Cprx, LLC | 2003 | — |
| −2 | K033401 | Modification to Resqpod Circulatory Enhancer | Advanced Circulatory Systems, Inc. | 2003 | — |
| −1 | K070490 | Cirqlator Intrathoracic Pressure Regulator (Itpr) | Advanced Circulatory Systems, Inc. | 2007 | — |
| 0 (this device) | K172388 | Vpod Itpr | Advanced Circulatory System, A Wholly Owned Subsidiary OF | 2017 | — |
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 |
|---|---|---|---|
| * | K070490 | Cirqlator Intrathoracic Pressure Regulator (Itpr)Summary page 4…Procode – BWF Incentive spirometer Class II Predicate Device: K070490 – ACS CirQlator™ Device Description: Advanced Circulatory Systems (“ACS”) which is now part of Zoll, received clearance for the… | 2007 |
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 14 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All BWF devicesBWF Spirometer, Therapeutic (Incentive): FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
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 VPOD™ Intrathoracic Pressure Regulator is indicated for the temporary decrease in intrathoracic pressure to increase blood circulation, as prescribed by a physician, licensed practitioner, or qualified technician.
Recommended duration of use is up to four hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172388 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172388: Vpod Itpr.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172388
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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