Cleared Traditional

K170185 - tremoFlo C-100 Airwave Oscillometry System (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K170185 · Thorasys Thoracic Medical Systems, Inc. · Anesthesiology device
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Sep 2017
Decision
232d
Days
Class 2
Risk

K170185 is an FDA 510(k) clearance for the tremoFlo C-100 Airwave Oscillometry System. Classified as Impedance Measuring Device Utilizing Oscillation Techniques (product code PNV), Class II - Special Controls.

Submitted by Thorasys Thoracic Medical Systems, Inc. (Montreal, CA). The FDA issued a Cleared decision on September 12, 2017 after a review of 232 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1840 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Thorasys Thoracic Medical Systems, Inc. devices

Submission Details

510(k) Number K170185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2017
Decision Date September 12, 2017
Days to Decision 232 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 139d · This submission: 232d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PNV Impedance Measuring Device Utilizing Oscillation Techniques
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1840
Definition This Device Measures Respiratory Impedance.
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 Anesthesiology devices follow this clearance model.