Cleared Traditional

K180011 - Pulmonx Chartis Tablet Console

K180011 is an FDA 510(k) clearance for Pulmonx Chartis Tablet Console, manufactured by Pulmonx Corporation. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K180011 · Pulmonx Corporation · Anesthesiology device
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Jul 2018
Decision
192d
Days
Class 2
Risk

K180011 is an FDA 510(k) clearance for the Pulmonx Chartis Tablet Console. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Pulmonx Corporation (Redwood City, US). The FDA issued a Cleared decision on July 13, 2018 after a review of 192 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 Pulmonx Corporation devices

FDA 510(k) Submission Details - K180011

510(k) Number K180011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2018
Decision Date July 13, 2018
Days to Decision 192 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
52d slower than avg
Panel avg: 140d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZG Device Classification - Class 2, Special Controls

Product Code BZG Spirometer, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1840
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.

Regulatory Peers - BZG Spirometer, Diagnostic

All 49
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