510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN250025Unknown

Syncron-E

Autonomous Healthcare, Inc., Santa Clara CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN250025 is the FDA 510(k) clearance record for Syncron-E, a class II device, cleared for Autonomous Healthcare, Inc. on under FDA product code QVC (Ventilator Waveform Analysis Software). FDA's definition for product code QVC reads: "Ventilator waveform analysis software is a prescription device that uses software algorithms to analyze mechanical ventilation waveform data to detect, display, and summarize patient-ventilator interactions. The device provides results to...". FDA records list one 510(k) clearance for Autonomous Healthcare, Inc. As of , FDA records show no recalls naming DEN250025.

Clearance record

Decision date
Received
(360 days to decision)
Product code
QVC Ventilator Waveform Analysis Software
Regulation
21 CFR 868.5896
Device class
Class II
Review panel
Anesthesiology
Applicant
Autonomous Healthcare, Inc. 3080 Olcott St., Suite C210, Santa Clara CA
Third party review
No

Clearances, product code QVC

Trailing 12 months
1 clearance under product code QVC in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QVC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260