510(k) · Cleared
Clearedtremoflo C2 Airwave Oscillometry System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thorasys Thoracic Medical Systems, Inc. · PNV Impedance Measuring Device Utilizing Oscillation Techniques
Cleared on Jun 20, 2023 as substantially equivalent to K170185 (Thorasys Thoracic Medical Systems, Inc., 2017) after a 440-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Jun 20, 2023
- Review
- 440 days
- Class
- Class II
- Product code
- PNV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K954140 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK954140 Masterscreen IosErich Jaeger GmbH & Co. KG · 1995
- 3 generations backK101873 Masterscreen IosCarefusion Germany 234 GmbH · 2011
- 2 generations backK152585 Resmon PRO FULLMedical Graphics Corp. · 2016
- 1 generation backK170185 tremoFlo C-100 Airwave Oscillometry SystemThorasys Thoracic Medical Systems, Inc. · 2017
- This deviceK221024 tremoflo C2 Airwave Oscillometry SystemThorasys Thoracic Medical Systems, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954140 | Masterscreen Ios | Erich Jaeger GmbH & Co. KG | 1995 | — |
| −3 | K101873 | Masterscreen Ios | Carefusion Germany 234 GmbH | 2011 | — |
| −2 | K152585 | Resmon PRO FULL | Medical Graphics Corp. | 2016 | — |
| −1 | K170185 | tremoFlo C-100 Airwave Oscillometry System | Thorasys Thoracic Medical Systems, Inc. | 2017 | — |
| 0 (this device) | K221024 | tremoflo C2 Airwave Oscillometry System | Thorasys Thoracic Medical Systems, Inc. | 2023 | — |
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 PNV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K170185 | tremoFlo C-100 Airwave Oscillometry SystemSummary page 4…r’s Name Brand Name 510(k) Number THORASYS Thoracic Medical Systems, Inc. tremoFlo C100 Airwave K170185 Oscillometry System Device Description: The tremoflo C2 Airwave Oscillom… | 2017 |
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 28 years and passes through 4 companies; a new generation was cleared every 5.8 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All PNV devicesPNV Impedance Measuring Device Utilizing Oscillation Techniques: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · PNV
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · PNV
Too few PNV 510(k)s in any year since 2007 to give a median.
Recalls per year · PNV
No recall names PNV since 2007.
Adverse event reports per year · PNV
No MAUDE report names PNV since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The tremoflo C2 Airwave Oscillometry System is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT). The tremoflo C2 Airwave Oscillometry System is intended for use with pediatric and adult patients 4 years of age or older. The device is designed to be used by pulmonologists, general practitioners, nurses, respiratory therapists, laboratory technologists, medical researchers and similarly trained personnel in hospitals, clinics, and private physician offices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221024 · printed Nov 3, 2026
Cite this page
510(k) Report. “K221024: tremoflo C2 Airwave Oscillometry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K221024
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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