510(k) Report

FDA applicant

Revolutionary Medical Devices, Inc.

Tucson, AZ2 decisions2017–20180 recalls

FDA records 2 decisions for Revolutionary Medical Devices, Inc. (Tucson, AZ) from 2017 to 2018: 2 510(k) clearances. Most are in product codes CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase) and BSJ (Mask, Gas, Anesthetic). Its devices cite 3 predicates, 1 of them its own earlier devices. 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 Revolutionary Medical Devices, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2017: 12018: 1
2017high 1 (2017) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Revolutionary Medical Devices, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Other applicant names beginning “Revolutionary”

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