Cleared Traditional

K221024 - tremoflo C2 Airwave Oscillometry System (FDA 510(k) Clearance)

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

K221024 · Thorasys Thoracic Medical Systems, Inc. · Anesthesiology device
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Jun 2023
Decision
440d
Days
Class 2
Risk

K221024 is an FDA 510(k) clearance for the tremoflo C2 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 June 20, 2023 after a review of 440 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Thorasys Thoracic Medical Systems, Inc. devices

Submission Details

510(k) Number K221024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2022
Decision Date June 20, 2023
Days to Decision 440 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
301d slower than avg
Panel avg: 139d · This submission: 440d
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.