Cleared Traditional

K170185 - tremoFlo C-100 Airwave Oscillometry System

K170185 is an FDA 510(k) clearance for tremoFlo C-100 Airwave Oscillometry System, manufactured by Thorasys Thoracic Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code PNV cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K170185 · Thorasys Thoracic Medical Systems, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K170185

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
92d slower than avg
Panel avg: 140d · This submission: 232d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PNV Device Classification - Class 2, Special Controls

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.