Cleared Special

K111764 - CHARTIS CONSOLE

K111764 is an FDA 510(k) clearance for CHARTIS CONSOLE, manufactured by Pulmonx, Inc.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Special 510(k) pathway after a 140-day FDA review.

K111764 · Pulmonx, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
140d
Days
Class 2
Risk

K111764 is an FDA 510(k) clearance for the CHARTIS CONSOLE. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Pulmonx, Inc. (Redwood City, US). The FDA issued a Cleared decision on November 10, 2011 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1840 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K111764

510(k) Number K111764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2011
Decision Date November 10, 2011
Days to Decision 140 days
Submission Type Special
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
At panel average
Panel avg: 140d · This submission: 140d
Pathway characteristics
Modification to existing cleared device.

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 158
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