Cleared Traditional

K131028 - PENTAX VIDEO BRONCHOSCOPES (EB FAMILY)

K131028 is an FDA 510(k) clearance for PENTAX VIDEO BRONCHOSCOPES (EB FAMILY), manufactured by Pentax Medical Company. The device is a Class 2 Ear, Nose, Throat device with product code EOQ cleared through the Traditional 510(k) pathway after a 363-day FDA review.

K131028 · Pentax Medical Company · Ear, Nose, Throat device
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Apr 2014
Decision
363d
Days
Class 2
Risk

K131028 is an FDA 510(k) clearance for the PENTAX VIDEO BRONCHOSCOPES (EB FAMILY). Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Pentax Medical Company (Montvale, US). The FDA issued a Cleared decision on April 10, 2014 after a review of 363 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Medical Company devices

FDA 510(k) Submission Details - K131028

510(k) Number K131028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2013
Decision Date April 10, 2014
Days to Decision 363 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
274d slower than avg
Panel avg: 89d · This submission: 363d
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
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K131028.
PENTAX Medical EKP-i5010 Video Processor with EB Family
K143727 · Pentax of America, Inc. · Oct 2015
CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved
K142934 · Covidien · Jun 2015
GenCut Core Biopsy System
K142839 · Covidien, LLC · Apr 2015
AMBU ASCOPE 3 5.0/2.2
K130845 · Ambu A/S · Nov 2013
EVIS EXERA III VIDEO SYSTEM
K121959 · Olympus Medical Systems Corp. · Jan 2013
FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530H
K122535 · Fujifilm Medical System U.S.A., Inc. · Dec 2012