510(k) · Cleared
ClearedResmon PRO FULL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Graphics Corp. · PNV Impedance Measuring Device Utilizing Oscillation Techniques
Cleared on Jun 24, 2016 as substantially equivalent to K101873 (Carefusion Germany 234 GmbH, 2011) after a 288-day review. Its family tree reaches back 2 generations to 1995. 2 later devices descend from it.
- Decided
- Jun 24, 2016
- Review
- 288 days
- Class
- Class II
- Product code
- PNV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K954140 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK954140 Masterscreen IosErich Jaeger GmbH & Co. KG · 1995
- 1 generation backK101873 Masterscreen IosCarefusion Germany 234 GmbH · 2011
- This deviceK152585 Resmon PRO FULLMedical Graphics Corp. · 2016
- Descendant · cites it directly · 1 of its ownK170185 tremoFlo C-100 Airwave Oscillometry SystemThorasys Thoracic Medical Systems, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK221024 tremoflo C2 Airwave Oscillometry SystemThorasys Thoracic Medical Systems, Inc. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954140 | Masterscreen Ios | Erich Jaeger GmbH & Co. KG | 1995 | — |
| −1 | K101873 | Masterscreen Ios | Carefusion Germany 234 GmbH | 2011 | — |
| 0 (this device) | K152585 | Resmon PRO FULL | Medical Graphics Corp. | 2016 | — |
| +1 | K170185 | tremoFlo C-100 Airwave Oscillometry System | Thorasys Thoracic Medical Systems, Inc. | 2017 | — |
| +2 | K221024 | tremoflo C2 Airwave Oscillometry System | Thorasys Thoracic Medical Systems, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2023 | 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 PNV? 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 PNV device
- #1 K221024 tremoflo C2 Airwave Oscillometry Systemscore 6.4 · 4 generations · no Class I recall
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 |
|---|---|---|---|
| * | K101873 | Masterscreen IosSummary page 4…culator, Pulmonary Function Data 21 CFR 868.1880, Class II Predicate Device: Carefusion MasterScreen IOS 510(k) K101873 Device Description: Resmon PRO FULL is a device for the assessment of the mechanical impedance based on the Forced Oscillation T… | 2011 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170185 | tremoFlo C-100 Airwave Oscillometry System | 2017 | 1 |
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 21 years and passes through 3 companies; a new generation was cleared every 15.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K170185 (Thorasys Thoracic Medical Systems, Inc., 2017) has gone furthest, with 1 descendant of its own.
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. 2016, 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 Resmon PRO FULL is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT). Resmon PRO FULL 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/K152585 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152585: Resmon PRO FULL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152585
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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