Cleared Traditional

K150280 - PulmoVia Working Channel

K150280 is an FDA 510(k) clearance for PulmoVia Working Channel, manufactured by Sanovas, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EOQ cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K150280 · Sanovas, Inc. · Ear, Nose, Throat device
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Jun 2015
Decision
126d
Days
Class 2
Risk

K150280 is an FDA 510(k) clearance for the PulmoVia Working Channel. Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Sanovas, Inc. (San Rafael, US). The FDA issued a Cleared decision on June 11, 2015 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4680 - the FDA ear, nose and throat 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Sanovas, Inc. devices

FDA 510(k) Submission Details - K150280

510(k) Number K150280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2015
Decision Date June 11, 2015
Days to Decision 126 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 89d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EOQ Device Classification - Class 2, Special Controls

Product Code EOQ Bronchoscope (flexible Or Rigid)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4680
Definition A Bronchoscope (flexible Or Rigid) And Accessories Is A Tubular Endoscopic Device With Any Of A Group Of Accessory Devices Which Attach To The Bronchoscope And Is Intended To Examine Or Treat The Larynx And Tracheobronchial Tree. If The Device Is Reprocessed, Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - EOQ Bronchoscope (flexible Or Rigid)

All 188
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