Cleared Traditional

K231546 - Somfit

K231546 is an FDA 510(k) clearance for Somfit, manufactured by Compumedics Limited. The device is a Class 2 Neurology device with product code MNR cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K231546 · Compumedics Limited · Neurology device
Download Printable Device Report (PDF)
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Nov 2023
Decision
184d
Days
Class 2
Risk

K231546 is an FDA 510(k) clearance for the Somfit. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Compumedics Limited (Abbotsford, AU). The FDA issued a Cleared decision on November 30, 2023 after a review of 184 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 868.2375 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Compumedics Limited devices

FDA 510(k) Submission Details - K231546

510(k) Number K231546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2023
Decision Date November 30, 2023
Days to Decision 184 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 148d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNR Device Classification - Class 2, Special Controls

Product Code MNR Ventilatory Effort Recorder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - MNR Ventilatory Effort Recorder

All 62
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