Cleared Traditional

AcuPebble Ox (200)

K243092 · Acurable Limited · Anesthesiology
Mar 2025
Decision
170d
Days
Class 2
Risk

About This 510(k) Submission

K243092 is an FDA 510(k) clearance for the AcuPebble Ox (200), a Ventilatory Effort Recorder (Class II — Special Controls, product code MNR), submitted by Acurable Limited (London, GB). The FDA issued a Cleared decision on March 19, 2025, 170 days after receiving the submission on September 30, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number K243092 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2024
Decision Date March 19, 2025
Days to Decision 170 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code MNR — Ventilatory Effort Recorder
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.2375