FDA applicant

Autonomous Healthcare, Inc.

Santa Clara, CA1 decision2026–20260 recalls

FDA records 1 decision for Autonomous Healthcare, Inc. (Santa Clara, CA) in 2026: 1 De Novo grant. All are in product code QVC (Ventilator Waveform Analysis Software). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Autonomous Healthcare, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2026

2026high 1 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

FIG. 1 — Autonomous Healthcare, Inc. by year, 2026–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Autonomous Healthcare, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Autonomous”

FDA records each applicant name separately; these may or may not be the same firm.

Autonomous Medical Devices Incorporated 1

Autonomous Healthcare, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Autonomous”