De Novo · Granted
GrantedSyncron-E
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Autonomous Healthcare, Inc. · QVC Ventilator Waveform Analysis Software
Granted on Jun 18, 2026 as a new device type through De Novo after a 360-day review.
- Decided
- Jun 18, 2026
- Review
- 360 days
- Class
- Class II
- Product code
- QVC
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo 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 QVC? 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
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.
How does its category compare?
All QVC devicesQVC Ventilator Waveform Analysis Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QVC
1so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QVC
Too few QVC 510(k)s in any year since 2007 to give a median.
Recalls per year · QVC
No recall names QVC since 2007.
Adverse event reports per year · QVC
No MAUDE report names QVC 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 | 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 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Syncron-E is a computer program (software) intended as an adjunctive aid for detecting evidence of ineffective efforts during exhalation and rest periods in previously recorded mechanical ventilation waveform data obtained while in volume control ventilation (VCV), pressure control ventilation (PCV), or pressure support ventilation (PSV) modes. Syncron-E is intended for respiratory therapists to analyze 30 to 60 minutes of previously recorded ventilator…
Read the full statement (105 words)
Syncron-E is a computer program (software) intended as an adjunctive aid for detecting evidence of ineffective efforts during exhalation and rest periods in previously recorded mechanical ventilation waveform data obtained while in volume control ventilation (VCV), pressure control ventilation (PCV), or pressure support ventilation (PSV) modes.
Syncron-E is intended for respiratory therapists to analyze 30 to 60 minutes of previously recorded ventilator waveform data per analysis session, and a summarized analysis is displayed for their review. Use is restricted to files obtained from adult patients 22 years and older receiving invasive ventilation.
The data is reviewed retrospectively and not to be used in time-sensitive scenarios.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN250025 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN250025: Syncron-E.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN250025
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026