Cleared Traditional

K183516 - PENTAX Medical Ultrasound Video Broncho...

K183516 is the FDA 510(k) clearance for PENTAX Medical Ultrasound Video Broncho... by Pentax of America, Inc.. It is a Class 2 Ear, Nose, Throat device (product code EOQ) cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K183516 · Pentax of America, Inc. · Ear, Nose, Throat device
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Sep 2019
Decision
262d
Days
Class 2
Risk

K183516 is an FDA 510(k) clearance for the PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U. Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Pentax of America, Inc. (Montvale, US). The FDA issued a Cleared decision on September 6, 2019 after a review of 262 days - an extended review 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. 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 Pentax of America, Inc. devices

Submission Details

510(k) Number K183516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2018
Decision Date September 06, 2019
Days to Decision 262 days
Submission Type Traditional
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
173d slower than avg
Panel avg: 89d · This submission: 262d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

Namsa, Inc.
Beryl St. Jeanne

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EOQ Bronchoscope (flexible Or Rigid)

All 176
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K183516.
Vathin Video Bronchoscope System
K191828 · Hunan Vathin Medical Instrument Co., Ltd. · Feb 2020
GlideScope BFlex 3.8 Single-Use Bronchoscope
K193488 · Verathon Medical (Canada) Ulc · Jan 2020
Ion Endoluminal System
K192367 · Intuitive Surgical, Inc. · Nov 2019
EVIS EXERA III Bronchovideoscope Olympus BF-XT190
K183419 · Olympus Medical Systems Corp. · Sep 2019
FUJIFILM Bronchoscope
K183607 · Fujifilm Corporation · Aug 2019
GlideScope BFlex 5.8 Single-Use Bronchoscope
K191948 · Verathon Medical (Canada) Ulc · Aug 2019