Cleared Traditional

K222861 - EVIS XI Video System Center Olympus CV-...

K222861 is the FDA 510(k) clearance for EVIS XI Video System Center Olympus CV-... by Olympus Medical Systems Corporation. It is a Class 2 Ear, Nose, Throat device (product code EOQ) cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K222861 · Olympus Medical Systems Corporation · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2023
Decision
266d
Days
Class 2
Risk

K222861 is an FDA 510(k) clearance for the EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H11.... Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Olympus Medical Systems Corporation (Tokyo, JP). The FDA issued a Cleared decision on June 15, 2023 after a review of 266 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 Olympus Medical Systems Corporation devices

Submission Details

510(k) Number K222861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2022
Decision Date June 15, 2023
Days to Decision 266 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
177d slower than avg
Panel avg: 89d · This submission: 266d
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

Olympus Corporation of the Americas
Brenda Geary

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 K222861.
Broncho Videoscope System
K231521 · Scivita Medical Technology Co., Ltd. · Nov 2023
Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set
K232582 · Ambu A/S · Sep 2023
Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2
K230428 · Ambu A/S · Aug 2023
Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance
K223299 · Ambu A/S · Jun 2023
Vathin® Video Bronchoscope System
K223836 · Hunan Vathin Medical Instrument Co., Ltd. · May 2023
BFlex™ 2 Slim 3.8 Single-Use Bronchoscope
K230948 · Verathon Medical (Canada) Ulc · May 2023