# DEN250025: Syncron-E

- Pathway: De Novo (Direct)
- Applicant: Autonomous Healthcare, Inc.
- Decided: Jun 18, 2026 after 360 days
- Product code: QVC (Ventilator Waveform Analysis Software)
- Device class: 2
- Regulation: 21 CFR 868.5896
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
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.

Source page: https://510kreport.com/device/DEN250025
Methodology: https://510kreport.com/methodology