Cleared Special

Somfit D

K252383 · Compumedics Limited · Neurology
Aug 2025
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K252383 is an FDA 510(k) clearance for the Somfit D, a Ventilatory Effort Recorder (Class II — Special Controls, product code MNR), submitted by Compumedics Limited (Abbotsford, AU). The FDA issued a Cleared decision on August 28, 2025, 28 days after receiving the submission on July 31, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number K252383 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 2025
Decision Date August 28, 2025
Days to Decision 28 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

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