Cleared Traditional

K231970 - PENTAX Medical Single Use Video Broncho...

K231970 is the FDA 510(k) clearance for PENTAX Medical Single Use 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 193-day FDA review.

K231970 · Pentax of America, Inc. · Ear, Nose, Throat device
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Jan 2024
Decision
193d
Days
Class 2
Risk

K231970 is an FDA 510(k) clearance for the PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single .... 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 January 12, 2024 after a review of 193 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 K231970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2023
Decision Date January 12, 2024
Days to Decision 193 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
104d slower than avg
Panel avg: 89d · This submission: 193d
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 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 K231970.
Bronchoscope System
K231107 · Hunan Endoso Life Technology Co., Ltd. · Feb 2024
FUJIFILM Endoscope Model EB-710XT
K240075 · Fujifilm Healthcare Americas Corporation · Feb 2024
PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
K232860 · Pentax of America, Inc. · Jan 2024
Ambu® aScope™ 5 Broncho 4.2/2.2
K233671 · Ambu A/S · Jan 2024
Ion Endoluminal System (IF1000)
K232984 · Intuitive Surgical, Inc. · Dec 2023
Broncho Videoscope System
K231521 · Scivita Medical Technology Co., Ltd. · Nov 2023