Cleared Special

GlideScope BFlex 5.8 Single-Use Bronchoscope (K191948) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K191948 · Verathon Medical (Canada) Ulc · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Aug 2019
Decision
30d
Days
Class 2
Risk

K191948 is an FDA 510(k) clearance for the GlideScope BFlex 5.8 Single-Use Bronchoscope. Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Verathon Medical (Canada) Ulc (Burnaby, CA). The FDA issued a Cleared decision on August 21, 2019 after a review of 30 days - a notably fast clearance cycle.

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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Verathon Medical (Canada) Ulc devices

Submission Details

510(k) Number K191948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2019
Decision Date August 21, 2019
Days to Decision 30 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 89d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 136
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K191948.
PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
K183516 · Pentax of America, Inc. · Sep 2019
EVIS EXERA III Bronchovideoscope Olympus BF-XT190
K183419 · Olympus Medical Systems Corp. · Sep 2019
FUJIFILM Bronchoscope
K183607 · Fujifilm Corporation · Aug 2019
PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus
K183654 · Pentax of America, Inc. · May 2019
FUJIFILM Video Bronchoscopes
K182253 · Fujifilm Corporation · Apr 2019
CoreDx™ Pulmonary Mini-Forceps
K183085 · Boston Scientific Corporation · Mar 2019