Cleared Traditional

K050220 - EVIS EXERA BRONCHOVIDEOSCOPE

K050220 is the FDA 510(k) clearance for EVIS EXERA BRONCHOVIDEOSCOPE 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 10-day FDA review.

K050220 · Olympus Medical Systems Corporation · Ear, Nose, Throat device
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Feb 2005
Decision
10d
Days
Class 2
Risk

K050220 is an FDA 510(k) clearance for the EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC. Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Olympus Medical Systems Corporation (Melville, US). The FDA issued a Cleared decision on February 10, 2005 after a review of 10 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Olympus Medical Systems Corporation devices

Submission Details

510(k) Number K050220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2005
Decision Date February 10, 2005
Days to Decision 10 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 89d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

Entela, Inc.
NED DEVINE

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 178
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K050220.
KARL STORZ VIDEO FLEXIBLE VIDEO ENT ENDOSCOPE SYSTEM
K071530 · KARL STORZ Endoscopy-America, Inc. · Aug 2007
EVIS EXERA 180 SYSTEM
K061313 · Olympus Medical Systems Corporation · Aug 2006
OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13
K060243 · Olympus Medical Systems Corporation · Jun 2006
EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412
K040018 · Boston Scientific Corp · Jan 2004
ENK FIBEROPTIC ATOMIZER SET
K031966 · Cook, Inc. · Oct 2003
EB-1830T3, VIDEO BRONCHOSCOPE
K023376 · Pentax Precision Instrument Corp. · Oct 2002

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.