510(k) · Cleared
ClearedSIMEOX 200 Airway Clearance Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inogen, Inc. · SDT Intra-Pulmonary Percussive Vibration (Ipv) Devices
Cleared on Dec 23, 2024 as substantially equivalent to K203209 (Airphysio Pty, Ltd., 2021) and 1 other predicate after a 245-day review. Its family tree reaches back 6 generations to 1988.
- Decided
- Dec 23, 2024
- Review
- 245 days
- Class
- Class II
- Product code
- SDT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K884098 (1988). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK884098 Thairapy (TM) Bronchial Drainage System, Model 101American Biosystems, Inc. · 1988
- 5 generations backK965192 Thairapy Vest SystemAmerican Biosystems, Inc. · 1997
- 4 generations backK993629 Abi Vest Airway Clearance SystemAmerican Biosystems, Inc. · 2000
- 3 generations backK012928 Abi Vest Airway Clearance SystemAdvanced Respiratory · 2001
- 2 generations backK024309 The Vest Airway Clearance System, Model 104Advanced Respiratory · 2003
- 1 generation backK122111 Respironics Simplyclear DeviceRespironics, Inc. · 2012
- This deviceK241091 SIMEOX 200 Airway Clearance DeviceInogen, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K884098 | Thairapy (TM) Bronchial Drainage System, Model 101 | American Biosystems, Inc. | 1988 | — |
| −5 | K965192 | Thairapy Vest System | American Biosystems, Inc. | 1997 | — |
| −4 | K993629 | Abi Vest Airway Clearance System | American Biosystems, Inc. | 2000 | — |
| −3 | K012928 | Abi Vest Airway Clearance System | Advanced Respiratory | 2001 | — |
| −2 | K024309 | The Vest Airway Clearance System, Model 104 | Advanced Respiratory | 2003 | — |
| −1 | K122111 | Respironics Simplyclear Device | Respironics, Inc. | 2012 | — |
| 0 (this device) | K241091 | SIMEOX 200 Airway Clearance Device | Inogen, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2021 | 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 SDT? 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? (2)
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 |
|---|---|---|---|
| * | K203209 | AirPhysio Positive Expiratory Pressure (PEP) DeviceSummary page 5…Class II PRIMARY PREDICATE DEVICE AirPhysio Positive Expiratory Pressure (PEP) Device (K203209) SECONDARY PREDICATE Philips Respironics SimplyClear Device (K122111) DEVICE DEVICE DESCRIPTION The SIMEOX 200… | 2021 |
| * | K122111 | Respironics Simplyclear DeviceSummary page 5…ysio Positive Expiratory Pressure (PEP) Device (K203209) SECONDARY PREDICATE Philips Respironics SimplyClear Device (K122111) DEVICE DEVICE DESCRIPTION The SIMEOX 200 Airway Clearance Device consists of a portable generator and a single patient use exp… | 2012 |
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 36 years and passes through 4 companies; a new generation was cleared every 8.5 years on median.
- 1 of the 13 ancestors has a recall of any class.
How does its category compare?
All SDT devicesSDT Intra-Pulmonary Percussive Vibration (Ipv) Devices: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · SDT
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · SDT
Too few SDT 510(k)s in any year since 2007 to give a median.
Recalls per year · SDT
No recall names SDT since 2007.
Adverse event reports per year · SDT
No MAUDE report names SDT 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 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SIMEOX 200 airway clearance device is intended to promote airway clearance and to improve bronchial drainage by enhancing mobilization of bronchial secretions via high frequency oscillatory vibrations and intermittent negative pressure to the airway during exhalation. The device is intended to be prescribed for use in patients capable of independently generating cough.
SIMEOX 200 is intended for use in the home, hospital, and other healthcare institutions by individuals weighing at least 23 Kg.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K241091 · printed Nov 5, 2026
Cite this page
510(k) Report. “K241091: SIMEOX 200 Airway Clearance Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K241091
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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